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Director, Quality & Regulatory
Posted 1 day ago
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**A Day in the Life**
Medtronic is hiring a Quality System Director. The person is Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
**Responsibilities may include the following and other duties may be assigned:**
-Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
-Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
-Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
-Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
-Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
-Co-ordinates legal requests in support of government investigations or litigations.
-Ensures the quality assurance programs and policies are maintained and modified regularly.
-Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
**Required Knowledge and Experience:**
-Autonomy: Manages department (s) or small unit that includes multiple teams led by managers and / or supervisors. Provides motivational leadership for the area managed. Provides thought and technical leadership. Performs work without appreciable direction.
-Organizational Impact: Leads the development of the strategy for own department or business area, ensuring links to the company's aims and objectives. Management authority to make large business decisions and some strategic decisions. Decisions impact the financial performance, employees, or public image of the operational unit and/or company. Typically has budget or P&L accountability for a department, broad functional area or geography.
-Innovation and Complexity: Drives innovation across the business area, encouraging best practice and knowledge sharing. Significantly improves, changes or adapts own department or business area's processes, systems, products or services. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
-Communication and Influence: Develops long term strategic relationships and alliances with key internal and external stakeholders. Communicates and conducts briefings with senior or executive leadership regarding ongoing operations and strategic initiatives. Influences across functions and businesses to negotiate and gain cooperation on operational issues and internal divergent objectives.
-Leadership and Talent Management Directs and leads a department, broad functional area or geography, including one or more teams led by managers and / or supervisors. Determines supervisory relationships and creates workforce and staffing plans to accomplish business results. Authorizes hiring, firing, Job Description promotion and reward within own area.
-Requires broad management and leadership knowledge to lead multiple job areas, and detailed functional and operational expertise. Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
This position is eligible for an annual long-term incentive plan.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
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Associate Director- Quality(US Healthcare)
Posted 10 days ago
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About Firstsource:
Firstsource Solutions is a leading provider of customized Business Process Management (BPM) services. Firstsource specializes in helping customers stay ahead of the curve through transformational solutions to reimagine business processes and deliver increased efficiency, deeper insights, and superior outcomes. We are trusted brand custodians and long-term partners to 100+ leading brands with presence in the US, UK, Philippines, and India. Our ‘rightshore’ delivery model offers solutions covering complete customer lifecycle across Healthcare, Telecommunications & Media and Banking, Financial Services & Insurance verticals. Our clientele includes Fortune 500 and FTSE 100 companies
POSITION DEFINITION:
This role will be responsible to lead the capability development teams across multiple clients/engagements. Is expected to strategize, implement, own and govern end to end learning interventions across all stages of the healthcare payer business. This includes identifying and assessing current and future training needs, continuously developing and improving training content and delivery methods, partner with content design team to create e-learning courses and work with internal stakeholders and clients to support in meeting key KPIs.
KEY ACCOUNTABILITIES/ RESPONSIBILITIES:
This leader of Training will be responsible for the following and will report into the Head of Capability Development for Healthcare
§ Oversee all Training needs within all Firstsource Healthcare Payer Training Operations
§ Build predictable insight models that lets the business stay ahead of curve
§ Meet KRA’s as agreed and any that may get added due to business needs
§ Responsible for developing and maintaining a training and development strategy for the Business
§ Collaborate with teams across geos and verticals to share best practices and drive continuous improvement
§ To oversee and ensure delivery of key training and development projects
§ Provide strategic and tactical inputs to RFPs from a learning standpoint
§ Lead the Training function for migration of new businesses from the Client site to desired work location.
§ Execute projects on improving speed to competence.
§ Work closely with the Client to understand their product/service and then design/customize the training content to ensure efficient knowledge transfer as may be required.
§ Create and deploy frameworks for instructional design and training evaluation
§ Work closely with Training Managers in the design and delivery of learning frameworks, practices and solutions during the development of the training program. Propose learning methodologies to best suit target audience.
§ Plan for resources (People and Infrastructure) in a timely manner to avoid delays and likely impact on business deliverables.
§ Manage budget for training tools and resources
§ Design and execute strong governance plans to communicate with the internal Customers, Stakeholders and Clients to gain information, feedback and approval.
§ Co-ordinate with other centres to share best practices, continuous improvement of content, delivery and ensure adherence to best practices identified in FSL training and on-job training.
§ Participate in key forums either at client site or any other site and be an ambassador of Firstsource on the whole for the program
§ Recommend solutions to complex problems while also accomplishing many projects and priorities day-to-day
REQUIRED KNOWLEDGE AND EXPERIENCE:
§ Graduate/Postgraduate with 15+ years’ experience – with atleast 12 years in healthcare (Payer)
§ Experience in creating and managing strategic learning frameworks and deploying new age learning tools / practices.
§ Experience in leading client interactions
§ Experience in working with diverse culture and multi-level Stakeholders.
§ Experience in developing and implementing training practices successfully across various client
§ Experience in transitioning new clients
§ Provide strategic and tactical inputs to RFPs from a learning standpoint
§ Proficient in Microsoft Office Tools: Excel, Access, Word, PowerPoint, Visio and content creation software
REQUIRED SKILLS:
· Excellent communication & presentation skills.
· Planning and Execution skills.
· Training Delivery and Content Digitization
· Ability to proactively identify current and future needs
· Good Interpersonal skills and analytical skills
· Ability to manage Customer critical metric performance.
· Self-driven and Assertive
· Strong People Management Skills
· Experience in leading Learning teams across locations
REQUIRED COMPETENCIES:
· Business Foresight –Ability to strategize & demonstrate deep business insight that helps identify & develop strategic opportunities.
· Influencing & driving excellence
· Managing Learning Transformation – Ability to work and lead transformations in a dynamic environment.
· Fostering partnerships with internal and external stakeholders
· Working across boundaries – collaborative working towards a “One Firstsource” identity
· Decision making & Solution oriented skills.
· Data orientation and strategic approach
️ Disclaimer: Firstsource follows a fair, transparent, and merit-based hiring process. We never ask for money at any stage. Beware of fraudulent offers and always verify through our official channels or @firstsource.com email addresses.
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Director– Customer Quality
Posted 10 days ago
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Enabling a software-defined, electrified future.
Visteon is a technology company that develops and builds innovative digital cockpit and electrification products at the leading-edge of the mobility revolution. Founded in 2000, Visteon brings decades of automotive intelligence combined with Silicon Valley speed to apply global insights that help transform the software-defined vehicle of the future for many of the world’s largest OEMs. The company employs 10,000 employees in 18 countries around the globe. To know more about us click here .
Role Overview:
The Customer Quality Leader will be responsible for driving customer satisfaction through proactive quality leadership across existing customers in India. This role will serve as the central escalation interface for customer quality concerns, lead a customer quality team to drive cross-functional problem-solving, and manage quality program execution through safe launch. The ideal candidate will foster a culture of quality excellence, collaborate with OEMs, and ensure seamless integration of quality processes across engineering, manufacturing, and supplier ecosystems.
Key Objectives of this Role:
- Manage customer quality scorecards, and ensure timely, accurate communication of quality data and reports.
- Develop and maintain Customer Quality Roadmaps aligned with strategic goals to meet performance indicators.
- Drive program-level quality management engineering, plant teams and suppliers to resolve quality issues and implement corrective actions.
- Build and maintain strong OEM relationships at senior management level to develop intimacy level that helps achieve quality targets and customer satisfaction.
- This includes negotiation of responsibility and cost sharing with OEMs, together with commercial team.
- Represent the company in customer management meetings, audits, and quality reviews.
- Lead and develop the Customer Quality team, promoting a culture of continuous improvement and customer focus.
- Ensure compliance with Customer Specific Requirements (CSR) across all quality and production steps.
- Support change management and validation processes to maintain product integrity and reliability.
Key Performance Indicators:
- Customer Scorecard ratings: Drive organization to meet customer 0KM, Warranty
- Quality Concern Responsiveness: Drive his team to meet 8D customer time closure expectations
- Financials: Manage financial impact of quality issues with respective internal departments to avoid any last-minute financial surprises.
Key Year One Deliverables:
Customer Engagement Framework:
Implement structured collaboration with OEMs to define expectations, engagement plan and proactively manage containment and permanent / preventive actions, improving CSS by 10%.
Data-Driven Quality Program:
Deploy analytics tools to identify trends and root causes, improving quality initiative effectiveness by 25%.
Issue Resolution Time:
Reduce average resolution time by 20% within the first year.
Qualification, Experience and Skills:
- Master’s/Bachelor’s degree in Engineering, Business Management, or related technical field.
- Minimum 15+ years of experience in automotive product delivery or/and quality management, preferably in a global or regional role.
- Proven experience in program management and customer-facing quality roles.
- Strong knowledge of automotive manufacturing, software development, and customer quality requirements.
- Proficiency in quality tools: FTA/Fishbone, APQP, PPAP, DFMEA, FMEA, MSA, SPC, Six Sigma.
- Preferred: Experience with QMS standards: ISO 9001, IATF 16949, ASPICE, ISO 26262.
- Excellent leadership, communication, and stakeholder management skills.
- Fluent in English; proficiency in Microsoft Office and quality reporting tools.
- Willingness to travel and support global OEMs and suppliers.
- Have Growth mindset
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Director of Quality Assurance
Posted 7 days ago
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About Randstad Enterprise
As the leading global talent solutions provider, Randstad Enterprise enables companies to create sustainable business value and agility by keeping people at the heart of their organizations. Part of Randstad N.V., we combine unmatched talent data and market insights with smart technologies and deep people expertise. Our integrated talent solutions — delivered by Randstad Advisory,
Randstad Sourceright and Randstad RiseSmart — help companies build skilled and agile workforces that move their businesses forward.
Randstad Enterprise supports some of the world's most renowned brands to build their talent acquisition and management models that not only meet their business needs today but also in the future. We offer solutions in Europe, Middle East and Africa (EMEA) region, Asia Pacific (APAC) region as well as in North America (NAM) region. This results in a digital way of working and requires a proactive mind-set.
● Our solutions know no limits, we have proven experience delivering market-leading MSP, RPO, Total Talent, and Services Procurement Solutions including technology, talent marketing, talent intelligence, and workforce consulting services.
● We create the best talent experience, from attraction to onboarding and onto ongoing career development, we understand the human and digital touchpoints that compel talent to join and stay with a company.
● We know where the talent of tomorrow is, how they behave, what they are looking for, and how to build their loyalty toward a specific company employer brand.
● We push the boundaries of our industry to be able to see around the corner for our clients, continually investing in innovation to stay ahead in our market.
As a Senior Director of Operations , BPO/RPO Quality you will have comprehensive operational and strategic accountability for the Quality Assurance function throughout our Google partnership. This leadership position demands a forward-thinking approach, where you will be instrumental in conceptualizing, developing, and executing robust business plans, refined processes, innovative strategies, and essential skill development initiatives. Your ultimate objective will be to significantly elevate the quality of our RPO and BPO services, fostering a partnership defined by excellence and continuous improvement.
In a highly consultative capacity, you will proactively identify, champion, and drive strategic initiatives designed to advance the delivery of services offered. This includes, but is not limited to, optimizing existing workflows, implementing best practices, integrating new technologies, and fostering a culture of quality-first within the operational teams. Your ability to translate strategic vision into actionable plans will be key to success.
Reporting directly to the VP of Operations, the Senior Director BPO/RPO Quality Operations will play a crucial supportive role for the VPs of both BPO and RPO functions. Operating within a dynamic, matrix-based environment, you will provide critical support to ensure that each workstream consistently achieves its Key Performance Indicators (KPIs) and Service Level Agreements (SLAs). Beyond mere compliance, a key aspect of your role will involve the consistent identification and proactive flagging of opportunities for efficiency gains. This includes analyzing performance data, conducting root cause analyses, and proposing solutions that not only resolve issues but also prevent recurrence, ultimately contributing to enhanced operational effectiveness and overall client satisfaction.
Duties and Responsibilities:
- Strategic leader for Quality Assurance, acting as owner and driver of initiatives within Quality organization and SPOC for Quality in Global, account-wide initiatives
- Analyzes Global Quality function by workstreams and regions, identifying larger trends and account risk, partnering with Senior Leadership to proactively identify, recommend and implement solutions.
- Partner with L&D and Delivery Directors to use trend analysis to create joint action plans and incorporate learnings into both training and process innovations
- Proactively identify opportunities to create efficiencies, add value and expand support provided
- Responsible for partnering with Delivery on overall P&L including forecasts
- Responsible for ensuring all teams meet SLAs and customer satisfaction targets
- Develop content and lead presentations for business and partnership reviews both internally and externally.
- Keep up to date on new/innovative methodologies needed to elevate current Quality Assurance offering to clients.
- Coach and mentor direct reports in their development within a global team
- Establish metrics, goals and expected performance levels for overall team productivity and provide feedback and coaching to direct reports where appropriate.
- Provide training where necessary on the appropriate skills and techniques
- Effectively manage and document performance and disciplinary actions as needed.
Position Requirements:
Basic qualifications include:
- Bachelors Degree in Business Management, or related field or 8-10 + years of equivalent work experience required
- 7-10+ years of related Quality Assurance, BPO, Recruiting and operational leadership and demonstrated successes within a complex organization
- 5+ years of experience managing and directing professional Quality Assurance teams within a client service role
Preferred qualifications include:
- MBA preferred in related field
- PHR, SPHR, PMI or similar disciplines preferred
- Experience managing a P&L, including forecasting
- LEAD Six Sigma Certification
- Ability to manage multiple teams or a single complex team; escalate conflicting priorities; influence team members and business leaders to successfully execute
- Ability to negotiate agreements and/or reach consensus with all levels and positions within the organization
- Superior consulting, leadership, management, interpersonal and mentoring skills
- Detail oriented with a passion for quality, initiating system and process improvements
- Management skills based on several years of experience preferably in a matrix based environment.
©Randstad Enterprise, Randstad RiseSmart & Randstad Sourceright are registered trademarks of Randstad N.V. We are committed to developing an inclusive and barrier-free recruitment process and work environment. If you require any reasonable accommodations, please let our Internal Talent Acquisition team know.
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Associate Director, Clinical Quality Assurance
Posted 1 day ago
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**Job Description**
**_Objective / Purpose:_** _Describe at the highest level the team where this job sits and how this role will contribute to the team's delivery of critical function._
+ Provides quality assurance oversight of the global and local clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU), and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.
+ Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice.
+ Defines and implements a risk-based program audit strategy, ensuring the communication of significant quality and compliance risks to key stakeholders and Management, and ensuring appropriate and timely investigations and mitigations are in place
+ Leads the inspection readiness programs, the management of the inspection, and the response and follow-up activities. Ensures that inspection risks are well-communicated and mitigated for both sponsor and investigator site inspections.
**_Accountabilities:_** _Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 - 10 bulleted task statements should be identified._
+ Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned development program teams and leadership
+ Assume complex assignments on issues or studies where there is no precedent
+ Mentor and provide support to Manager level CPQ personnel, as needed
+ Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, clinical trial delivery, documents, databases, vendors, or internal systems in compliance with GCP and Takeda policies and procedures.
+ Assess the impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CPMQ management.
+ Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
+ Lead or assist with investigations into significant quality issues, scientific misconduct, and serious breaches of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
+ Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions
+ Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation
+ Collaborate with Clinical Safety Quality Compliance team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups.
+ Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
+ Participate in due diligence activities and process improvement initiatives as requested by management
**_Education & Competencies (Technical and Behavioral):_** _List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted._
+ BA/BS degree required; advanced degree preferred.
+ Minimum of 10 -15 years of experience in the pharmaceutical, biotechnology or related health care industry.
+ Minimum 12-15 years of GCP-related Quality Assurance or relevant clinical trial experience.
+ Recent experience in leading and hosting India Central Drugs Standard Control Organization (CDSCO) inspection and other health authority inspection experience with FDA, MHRA etc.
+ Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
+ Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective action plans that mitigate risks to the company, patient safety and data integrity.
+ Collaborative team player proficient in stakeholder management, possessing a positive attitude, critical thinking skills, and the ability to swiftly identify creative solutions to complex problems
+ Strong technical writing skills; able to write quality positions, audit reports, and procedures.
+ Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
+ Strong judgment, project management, and decision-making skills; able to manage multiple projects and demanding timelines
+ Superior attention to detail and ability to analyze complex data
+ Able to travel to various meetings, inspections and/or audits, including overnight trips and international travel.
**Locations**
IND - Bengaluru
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
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Quality Management Officer
Posted today
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Interface with external parties, including vendors and regulatory bodies, to manage quality expectations.
Provide detailed reports and recommendations to senior management regarding quality improvement initiatives.
Company Overview
Sri Sai Overseas Recruitment is a leading Manpower Recruitment & Consultancy Service provider founded in 2019. Headquartered in Vadodara, the company specializes in delivering exceptional recruitment services in India, the Middle East, Europe, and beyond. With expertise gained from professionals experienced in the Gulf countries' Oil & Gas sectors, Sri Sai Overseas Recruitment is committed to understanding and fulfilling client needs across diverse industries globally. For more details, visit our website at Sri Sai Overseas Recruitment .
Job Overview
We are seeking a qualified Junior-level Quality Management Officer to join our team at our Vadodara headquarters. This full-time role involves ensuring compliance across various projects and maintaining high-quality standards. The position is ideal for professionals keen to ensure quality assurance practices and operations. With a dedicated team, Sri Sai Overseas Recruitment is committed to aligning with client needs and ensuring successful global placements.
Qualifications and Skills
- Proficiency in performing root cause analysis to identify problems and recommend effective solutions.
- Experience with statistical process control to monitor and control quality assurance processes.
- Familiarity with total quality management principles aimed at enhancing quality standards and performance.
- Capability to conduct quality audits and ensure processes comply with regulations.
- Understanding of microbiology principles relevant to quality control and assurance.
- Ability to develop and maintain standard operating procedures to enhance operational efficiency.
- Experience in total quality management for consistency and quality in processes.
- Proficiency in FDA regulations (Mandatory skill for ensuring product safety and compliance).
Roles and Responsibilities
- Indent and receipt media, chemicals, reagents for microbiology lab and maintain receipt records.
- Maintain daily usage logbooks of Balance, water bath, PH Meter, Laminar Airflow, Incubator, Fogger, and Antibiotic zone reader & colony counter.
- Maintain daily monitoring records of Refrigerators temperature, incubator temperature, relative humidity (RH), temperature & differential pressure.
- Keep calibration records of PH Meter and analytical balance, as well as all instruments in the Microbiology department.
- Maintain disinfectant preparation & microbiology area and instruments cleaning records.
- Maintain environment monitoring records of settle plate & air sampler methods.
- Prepare MLT reports of raw materials, bulk & finished products.
- Indent media and chemicals required in the microbiology lab.
- Carry out Growth promotion tests (GPT) as per SOP.
- Document daily media preparation & its record as per SOP.
- Maintain autoclave sterilization record of slow exhaust cycle & HPHV cycle.
- Conduct water sampling, analysis & record as per SOP.
- Perform microbial limit test (MLT) of stability products, bulk, raw material & its record as per SOP.
- Conduct bioassay of B12 for bulk.
- Document culture dilution & its records.
- Maintain subculturing and its records.
- Perform swab, rinse, and drains analysis.
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Senior Director, Site Quality Head, Goa
Posted 1 day ago
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Date: Oct 5, 2025
Location:
Goa, India,
Company: Teva Pharmaceuticals
Job Id: 61480
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products.
This oversight includes but is not limited to the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA Creation and implementation; trending and metrics, compliance with validation requirements; verification that equipment, facility and utility systems are maintained in accordance with established requirements.
Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of Quality Systems, global and local compliance programs, industry practices, and corporate quality initiatives. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices
**Location**
This role is based on the Teva site in Goa, India.
**How you'll spend your day**
+ Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations.
+ Ensure a current Quality Management System is in place and continuously improved
+ Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications.
+ Most senior professional and independent decision maker authority on product quality and potential market actions
+ Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
+ Design and Implement the Site Quality Program-Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.
+ Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance
+ Direct Quality Control-- Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site
+ Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality
+ Maintain strong partnership with site leadership team
+ Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met
+ Provide effective Quality leadership during internal, customer and Health Authority inspections
+ Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically
+ Plans, manages and monitors the annual Quality Operations budget and all its resources and employees. Ensure the performance and utilization of resources to provide maximum efficiency to the organization.
**Your experience and qualifications**
+ Required - bachelor's degree in chemistry, Biology, Pharmacy
+ Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy
Key Requirements:
+ Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including:
+ Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process,
+ High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions,
+ Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types,
+ Strong understanding and experience in Data Integrity and Compliance
+ Experience preparing and/ or leading regulatory authority GMP
+ Deep knowledge of Quality Systems
+ Proven successful track record of leading organizational change to improve efficiency
+ Experience leading, inspiring and coaching large teams
+ Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes
+ Must have adequate knowledge of Quality best practices
+ Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control
+ Must have adequate practical knowledge of analytical techniques and microbiological principles
+ Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer
+ Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools
+ Good knowledge of environmental, health and safety requirements for laboratories and quality operations.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran
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Director of Pharmaceutical Quality Assurance
Posted 16 days ago
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Assistant Manager-Quality Management
Posted 10 days ago
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Role- Assist-Manager Quality
Experience-8+Years
Location-Hyderabad
Mandatory skills- Quality, Quality consulting, CMMI 3.0, Agile,
Metric and analysis, Agile Methodology & CMMI Practices.
Project Lifecycle Support Initiation, Execution, Closure.
LEAN, Six Sigma, Zero Distance Initiatives.
Vulnerability Management Tools Scan Execution & Reporting.
SOC Audit Handling & ASAM Ticket Management.
Roles and Responsibilitiy,
1. Introduction
This JD provides an overview of the Software Quality Advisors role and responsibilities.
1.1 Scope of Software Quality Advisor (SQA) Role
The basic objectives of the Software Quality Advisors role are to:
- Assist project to implement Quality Management System (QMS)
- Provide relevant process related training.
- Ensure compliance to projects planned processes.
- Assist in metrics and milestone analysis.
- Perform a closure analysis at project closure.
Skill Set
- CMMI Integrated V2.0 framework.
- ISO Integrated 9001:2015 and ISO 20K standards.
- Quantitative Project Management Building prediction models & Alternative models.
- Agile Methodology/ CMMI Implementation
- Value stream mapping workshop, Demand Capacity & Reduction analysis, Meeting time analysis, Documentation analysis, DILO & Context switching analysis, Management time analysis, Team structure analysis, Span of control analysis, Skill heat-map analysis, Individual variability analysis & Onsite team optimization etc.
- Improve delivery practices leading to significant and sustainable Productivity Improvement in FP projects.
- Contract renewal, T&M to FP conversion, new business wins, meet committed productivity numbers in non-FP projects.
- Improve estimation practices for new bids.
- Worked on Excel, Power BI Report builder, R Studio & Process model (SVC)
2. Software Quality Advisor Activities
SQAs activities can be split across two main streams:
- Process Consultation
- Continuous Improvement
2.1 Process Consultation to the project team during the following phases of a project
- Project Initiation
- Project Execution
- Project Closure Activities
2.1.1 Project Initiation Activities:
During the project initiation phase, the activities that are SQA would assist the project manager and project team would include,
- Understand the scope of the project, client quality requirements along with contractual commitments.
- Understand the interdependencies between various teams which are involved in meeting the clients' requirements.
- Organize a Project Kick Off meeting with all the relevant stakeholders. (Refer Project kick-off ppt template in the Quality Teams SharePoint site under Project Management (PM) Templates for the required details for this meeting)
- Assist the Project manager in tailoring the appropriate processes and guidelines for the execution of the project.
- Set up the project goals for the project based on the objectives of the project.
- Assist the Project Manager in orientation on the Quality system and customizing of the same.
- Ensure that the scientific techniques for Estimation (Function Point (FP), SMC, etc.) and Scheduling are used.
- Assist in identification of Risks in the project and setting up of mitigation plan of the risk.
- Identify the need for process training amongst the project team members and plan for organizing the same Prepare the SQA plan for the project with details of strategies, project review and enabling plan.
- Assist Project Manager in identifying and deploying Organization Level Initiatives in the Project like Zero Distance, LEAN, Six Sigma, etc.
- Participate in group review of Project management plan and Configuration management plan.
2.1.2 Project Execution Activities:
Following are the primary activities that are performed by the SQA, during project execution.
- Conduct frequent health checks of the project. Partner the projects in understanding the Top issues and consult them in mitigating it.
- Monitor the progress of the project using Project Performance Snapshot (PPS).
- Verify Project’s Compliance to the processes defined in the project management plan as per the Review plan defined in the SQA plan.
- Provide a detailed report (PPS) to all the stakeholders on the compliance status of the project.
- Assist during Internal audit for the project which is scheduled. Track the closure of Non-conformances raised in the audit.
- Assist the Project Manager in analyzing the customer feedback for the project on a periodic basis
- Participate in Causal Analysis & Resolution (CAR) meetings, Defect Prevention (DP) meetings for the project as required.
- Perform Periodic analysis of the project’s data and present to the Stakeholders (Project Team, Delivery Manager (DM) and Senior Leadership).
- Drive the implementation of Organization Level / Project Level initiatives to achieve goals.
- Assist Project Managers to participate in various Reward & Recognition programs.
2.1.3 Project Closure Activities:
During the closure phase of the project, the SQA will
- Assist the Project Manager in preparing the final PPS report for the project within the provided timelines.
- Analyse the Quality and Productivity parameters for any deviations.
- Capture the lessons learned from the project execution for future reference.
- Assist the Project Manager in closing the project in all relevant systems.
A detailed checklist of activities for the SQA is given in this document for reference. Deliverables of the SQA are also described in this document.
2.2 Partnering the DU/Unit/Organization in continuous improvement: The list of activities would include.
- Provide periodic reports to the Delivery management on the hygiene status, process performance status along with details of initiative rollout status
- Proactively identify areas of risk and assist the delivery teams in mitigating the risks.
- Identifying the opportunities for improvement and Rollout of Change Initiatives across the DU/Unit/Account/Organization
- Conduct structured analysis on the past process performance of the DU/Unit/Account/Organization on a periodic basis.
- Identify the areas of focus and opportunities for improvement in the coming period.
- Partner with delivery teams in identifying strategies for actionizing on the improvement opportunities
- Ensure deployment of strategies identified across the projects
- Monitor the status of deployment and results.
- Provide strategic support in driving delivering excellence and client satisfaction
3. Deliverables
Below are the deliverables that are expected of a SQA
- SQA Plan
- Compliance reports and the Non-Conformance closure report if any.
- Data analysis reports (if any)
- Closure reports (PPS)
- Any other reports that the SQA has prepared for the project.
- Training records
- Lessons Learned or Process Improvement suggestions.
In case of change in the SQA, previous activities & artifacts including project related mails shall be handed over to the new SQA.
4. SQA Reports to Management
SQA must send the Project Performance Report with a minimum frequency of once per week to the DM and Quality Manager, or as agreed between them.
The structure of the report can be decided based on the requirements of the stakeholders. Some of the details that the report could contain includes,
- Activities Performed during the period ex: Compliance check, Internal Audits, Reviews etc. and pending actions or NCRs.
- Risk Status
- CMMi status
- Hygiene
- Casual Analysis and Resolution
- Metrics
- CM audit
- Organization / Unit level Improvement Initiatives Status
- Quality and Productivity values and analysis for the deviation.
- Issues needing DM's attention.
5. Handling vulnerability management
- Hands on experience on any vulnerability management tool.
- Able to run the scans/reports on any tool.
- Expertise in addressing tool issue.
- To Handle access related and license renewal related issues.
- Trouble shoot on any tool issues and guiding team in fixing them.
- Able to coordinate with external stake holders/vendors.
- Coordinating with project teams on scan template reviews.
- Identify the severity of vulnerability/issue and guide project teams in addressing the fixes.
- Handling code moves, ASAM tickets and SOC audits.
Regards,
Infosys BPM Recruitment team
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Sap Quality Management Consultant
Posted 10 days ago
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Role Summary:
We are seeking a seasoned Senior SAP QM Consultant to lead and deliver end-to-end SAP Quality Management implementation. The ideal candidate will possess a strong understanding of procured material inspection processes—including quality planning, inspection execution, continuous improvement, root cause analysis, and analytics—and demonstrate deep expertise in SAP QM functionalities. This includes seamless integration with other SAP modules and hands-on experience across the full project lifecycle: blueprinting, configuration, testing, training, and go-live support.
Key Responsibilities:
- Lead SAP QM module implementation across multiple phases: requirement gathering, design, configuration, testing, deployment, and post-go-live support.
- Collaborate with business stakeholders to understand quality processes and translate them into SAP solutions.
- Configure SAP QM functionalities including inspection planning, results recording, quality notifications, and audit management.
- Integrate QM with SAP PP, MM, SD, and other relevant modules.
- Prepare functional specifications for custom developments and coordinate with ABAP developers.
- Conduct workshops, training sessions, and UAT with business users.
- Manage project timelines, deliverables, and stakeholder communication.
- Provide expert-level troubleshooting and support during hypercare.
- Ensure compliance with industry standards and internal quality policies.
Required Qualifications:
- Bachelor’s or Master’s degree in Engineering, IT, or related field.
- 10+ years of SAP QM experience with at least 3 full-cycle implementations.
- Strong understanding of manufacturing and quality processes.
- Experience with SAP ECC and/or S/4HANA environments.
- Proficiency in integration with SAP PP, MM, SD.
- Excellent communication, leadership, and stakeholder management skills.
- Ability to work independently and lead cross-functional teams.
Preferred Skills:
- SAP QM certification.
- Familiarity with tools like LSMW, interfaces and Fiori apps.
- Six Sigma methodology
- Knowledge of Agile or hybrid project methodologies.
- Build Control Charts based on specifications like CTQ etc, alerting mechanism and follow-up actions by suppliers or parts . Capture summary of observations and actions in a Dashboard
- Applying AI/ML to predict quality of supplier parts
- Experience in Semiconductor or repetitive manufacturing Industry.
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