1,310 Product Quality jobs in India

**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**What you will do**
Let's do this. Let's change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions.
Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.
This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health.
+ Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ)
+ Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc.
**What we expect of you**
**Basic Qualifications and Experience:**
+ Master's degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8-13 years of Quality, Operations, Scientific, or Manufacturing experience
**Preferred Qualifications:**
**Must-Have Skills:**
+ Demonstrate proficiency in Biologics manufacturing process including analytical methods.
+ Experience with authoring comparability protocols, product specifications and stability assessments.
+ Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers
+ Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
+ Strong scientific data management and organization skills with attention to detail
+ Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems
+ Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills
**Good-to-Have Skills:**
+ Experience working virtually on a multi-functional team in a matrix environment across multiple time zones
+ Hands-on experience with combination products such as pre-filled syringes (PFS), pen injectors and automatic pen injectors
+ Expertise in computer applications such as Veeva, Spotfire, SHINY
+ Expertise in MS Office (Word, Excel, PowerPoint, MS Teams)
**Soft Skills:**
+ Analytical and problem-solving skills
+ Ability to work effectively with global, virtual teams
+ High degree of initiative and self-motivation
+ Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
+ Team-oriented, with a focus on achieving team goals
+ Strong presentation and public speaking skills
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

LinkedIn is the world's largest professional network, built to create economic opportunity for every member of the global workforce. Our products help people make powerful connections, discover exciting opportunities, build necessary skills, and gain valuable insights every day. We're also committed to providing transformational opportunities for our own employees by investing in their growth. We aspire to create a culture that's built on trust, care, inclusion, and fun - where everyone can succeed.
Join us to transform the way the world works.
At LinkedIn, our approach to flexible work is centered on trust and optimized for culture, connection, clarity, and the evolving needs of our business. The work location of this role is hybrid, meaning it will be performed both from home and from a LinkedIn office on select days, as determined by the business needs of the team.
As a Lead Product Quality Evaluator (PQE) you will evaluate the product quality of new LinkedIn products and features. You will assess the readiness of our latest changes prior to their being released through the planning and testing across the entire portfolio of LinkedIn's products. These product evaluations will include black box manual, functional testing, accessibility testing, exploratory testing, API testing, and GenAI prompt scoring. You will join a team of member-focused product evaluators who work with product managers, engineers, and designers, to help evaluate and improve the features that make our members successful each and every day.
As a Lead PQE, you will develop a high level of competence for LinkedIn's core products and expected functionality, as well as less commonly used features of LinkedIn. You'll test new and nuanced features, flows, and functionalities. You will establish a leadership role with peers and interact with upper management. You'll influence product and engineering decisions and lead the quality of key launches.
**Responsibilities:**
+ Independently evaluate the next generation of product features and functionalities. Make recommendations to improve product quality and functionality.
+ Convert business requirements into structured test cases and execute test deliverables.
+ Create test plans with multiple work streams and dependencies. Manage test execution across the organization.
+ Prioritize and estimate the level of effort on multiple projects in parallel. Proactively communicate with stakeholders as the single point of contact for the UAPe team.
+ Performed functional, regression, integration, accessibility, API, GenAI and UI testing.
+ Use expert product knowledge, advanced research, and error logs to identify product issues to create reproducible bug reports.
+ Effectively present technical and functional details to senior leaders with both technical and non-technical backgrounds and provide sign-off on product readiness for public launch.
+ Independently work with engineers and product managers to provide member perspective on features such that they meet market needs with respect to functionality, usability, privacy, and performance.
+ Collaborate across the organization to articulate issues, its severity, impact and potential solutions.
+ Independently use data to effectively influence engineering to fix issues before launch.
+ Independently escalates issues to senior leadership and drives effective and collaborative resolutions.
+ Use advanced understanding of JIRA to identify trends and areas of improvement for stakeholders.
+ Coach and mentor full-time employees and vendors to adopt high quality evaluation standards and industry best practices.
**Basic Qualifications:**
+ BE/BS/BA degree required
+ 7+ years' experience in one or more of the following areas: User Testing, Product Evaluation, Quality Assurance, User Experience, Technical Program/Project Management, Test Engineering, or Technical Support.
+ 3+ yrs experience with testing APIs
+ 2+ yrs experience with test automation tools and scripting/programming languages - Postman, Selenium, Appium, Java, Javascript, Python, Playwright etc.
+ Experience in Agile Testing practices
+ Advanced knowledge of JIRA for bug filing, sprint planning, and test case scenarios.
+ Experience in coaching and mentoring team members
**Preferred Qualifications: **
+ Experience with GenAI products testing
+ Experience with Accessibility testing
+ Experience working with vendors to test
**India Disability Policy**
LinkedIn is an equal employment opportunity employer offering opportunities to all job seekers, including individuals with disabilities. For more information on our equal opportunity policy, please visit Data Privacy Notice for Job Candidates **
Please follow this link to access the document that provides transparency around the way in which LinkedIn handles personal data of employees and job applicants:

Wabtec Corporation is a leading global provider of equipment, systems, digital solutions and value-added services for freight and transit rail. Drawing on nearly four centuries of collective experience across Wabtec, GE Transportation and Faiveley Transport, the company has unmatched digital expertise, technological innovation, and world-class manufacturing and services, enabling the digital-rail-and-transit ecosystems. Wabtec is focused on performance that drives progress, creating transportation solutions that move and improve the world. Wabtec has approximately 27,000 employees in facilities throughout the world. Visit the company's new website at: .
It's not just about your career. or your job title.it's about who you are and the impact you are going to make on the world. Do you want to go into uncharted waters.do things that haven't been done to make yours and someone else's life better? Wabtec has been doing that for decades and we will continue to do so! Through our people, leadership development, services, technology and scale, Wabtec delivers better outcomes for global customers by speaking the language of industry.
**Key missions of the position:**
+ Managing Product Quality Activities
+ Hand on experience in Brakes system, Air Generation Compressor & Motor
+ Managing Customer Requirements & Deliverables
+ Achieving Departmental & Company KPIs
**Main responsibilities:**
+ Having good knowledge in Product Management concepts
+ Understanding the needs of Customers on Quality Perspective
+ Maintaining Product Deliverables with internal & external teams
+ Communications with Internal & External stakeholders
+ Must have effective team management skills
+ Well versed with Quality assurance processes & systems
+ Having good knowledge in Basic Mechanical Engineering Concepts
+ Having good analytical skills
+ Managing Internal & External Non-Conformities
+ Experience in handling Measuring Instruments
+ Carry out part & sub-assembly level inspections
+ Implementing New systems / processes as improvement (Poka-Yoke/Kaizens, etc.)
+ **What education and education level are necessary for the position** ?
+ B.E / B.Tech Mechanical Engineering
How many years of professional experience in a specific professional area are required for the position?
15 years exposure in similar Industry.
Wabtec Corporation is committed to taking on the world's toughest challenges. In order to fulfill that commitment we rely on a culture of leadership, diversity and inclusiveness. We aim to employ the world's brightest minds to help us create a limitless source of ideas and opportunities. We believe in hiring talented people of varied backgrounds, experiences and styles.people like you! Wabtec Corporation is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or expression, or protected Veteran status. If you have a disability or special need that requires accommodation, please let us know.

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Key Responsibilities**
As an Individual contributor:
The Annual Product Review (APQR) Manager-Will primarily manage the Global BMS site APQR program by authoring and completing the APQRs for all BMS commercial Marketed Products. The APQR manager will be responsible for the completion of this annual compliance expectation by partnering with the site to draft and compete document from final approval.
The APQR specialist will be responsible for the following defined roles and responsibilities:
+ Responsible to provide oversight and completion of the site APQRs
+ Responsible for authoring through approval of APQRS assigned, per site APQRs per schedule
+ Responsible for ensuring any site or CMO APQR is created following the effective process and procedures
+ Responsible for updates to the APQR program requiring SOP, WI and/or training
+ Provide in depth quality and compliance oversight during report authoring and reviewing.
+ Responsible for ensuring all elements of the AQPR procedure are compliantly fulfilled.
+ Responsible for facilitating review and approval meetings, problem-solving key issues, and effectively managing communications with key stakeholders.
+ Responsible to escalate any deficiencies in the draft APQR which cannot be resolved with the working team
+ Responsible for projecting and communicating stakeholder actions and timing.
+ Responsible for escalation of risk to management if not meeting the completion date.
+ Responsible for providing opportunities for process improvement and standardization.
+ Supporting onboarding and training of more junior team members
+ Support, as required, the implementation and/or maintenance of additional QA Systems, which may include (but is not limited to) APQR program documentation, Change Control, Quality Risk Management, Product Quality Complaints and Annual Product Quality Reviews
+ Support, as required, Digitalization/automation/efforts for the APQR program
**Qualifications & Experience**
**Specific Knowledge, Skills, Abilities:**
+ Demonstrated knowledge of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes required.
+ Completes work with periodic check in with direct manager
+ Experience in a GMP Quality role required in a commercial operations setting
+ Demonstrated experience in authoring and completing site APQRs
+ Ability to drive consensus, performance and to lead strategically
+ Prior experience with navigating multiple Quality Management systems.
+ Demonstrated strategic and tactical thinking capability with strong project management skills and ability to focus on execution of strategic decisions.
+ Solid negotiating and influencing skills in a matrixed organization.
+ Ability to work in a global matrix environment.
+ Ability to build strong relationships by being transparent, reliable, and delivering on commitments.
+ Effective communication skills.
+ Ability to provide innovative ideas, align and make decisions balancing speed, quality, and risk.
+ Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.
**Education:**
+ Minimum 5 years of experience in a quality, and/or regulatory role within the biopharmaceutical industry with demonstrated expertise in Quality Compliance, or Operations preferred.
**Travel:**
+ Must have ability to travel to US required (specifically for training purposes)
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :01:00.082 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

OVERVIEW

An opportunity for a mechanical engineer interested to build a career on product inspection & testing.

COMPETENCY

• Knowledge / understanding on,
• - Product inspection using measuring instruments (e.g. Vernier Caliper, Micrometer, Gauges) including extracting requirements from product’s drawing, specification, etc.
• - Product Testing (Mechanical)
• - Ancillary activities eg preparation of inspection report
• - Product specifications / standards,
• - Quality documents & procedures
• - Product sampling
• Able to communicate in English (both verbal & written)
• Preference will be given to applicants,

- Having knowledge of ISO 9001

- Using Microsoft Excel in day-to-day working

QUALIFICATIONS

• Bachelor/Diploma in Mechanical Engineering or equivalent

RESPONSIBILITIES

• Product inspection
• Product Testing (Mechanical)
• Setup Approval for production
• Line inspection of production
• Ancillary QAQC activities, preparation of reports for all above activities

Perks and Benefits:

Based on candidates competency level.

Workplace:

Tekno Valves , Natun Rasta, Sodepur, Kolkata

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Key Responsibilities**
As an Individual contributor:
The Annual Product Review (APQR) Specialist -Will primarily manage the Global BMS site APQR program by leading and generating the APQRs for all commercial Marketed Products. The APQR specialist will be responsible for the completion of this annual compliance expectation by leading a team of Subject Matter Experts to draft and compete document from draft to final approval and delivery to the key stakeholders in alignment with the prescribed schedule.
The APQR specialist will be responsible for the following defined roles and responsibilities:
+ Responsible to provide oversight and completion of the site APQRs
+ Responsible for authoring of APQRS assigned, per site APQRs per schedule
+ Responsible for ensuring any site or CMO APQR is created following the effective process and procedures
+ Provide in depth quality and compliance oversight during report authoring.
+ Responsible for ensuring all elements of the AQPR procedure are fulfilled accurately.
+ Responsible for facilitating review and approval meetings, problem-solving key issues, and effectively managing communications with key stakeholders.
+ Responsible for collecting review feedback and resolving comments and questions.
+ Responsible for projecting and communicating stakeholder actions and timing.
+ Responsible to escalate any deficiencies in the draft APQR which cannot be resolved with the working team
+ Responsible for escalation of risk to not meeting the completion date.
+ Responsible for providing opportunities for process improvement.
+ Accountable to adhere to GMPs and BMS Policies and Procedures
+ Support as may be required, the implementation and/or maintenance of additional QA Systems, which may include (but is not limited to) APQR program documentation, Change Control, Quality Risk Management, Product Quality Complaints and Annual Product Quality Reviews
+ Support as required Digitalization/automation/efforts for the APQR program
**Qualifications & Experience**
**Specific Knowledge, Skills, Abilities:**
+ Understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes required.
+ Works with the routine oversight on direct manager.
+ Experience in a GMP Quality role required
+ Experience in authoring APQRs
+ Prior experience with navigating Quality Management systems.
+ Demonstrated tactical thinking capability with strong project management skills.
+ Ability to work in a global environment.
+ Demonstrated negotiating and influencing skills in a matrixed organization.
+ Ability to build strong relationships by being transparent, reliable, and delivering on commitments.
+ Effective communication skills.
+ Ability to provide innovative ideas, align and make decisions balancing speed, quality, and risk.
+ Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.
**Education:**
+ Minimum 3 years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated acumen in Quality Compliance or Operations preferred.
**Travel:**
+ Must have ability to travel to US required (specifically for training purposes)
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :01:00.082 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Product ( Fabric ) Development Manager

B E. Textile Chemistry , Coated fabric develops , PVR & PU Coated Fabric , Strong knowledge of PVC coating , PU coating , PVDF lacquered chemicals formulation , Print Media , coating and new product development in various coated application .

Hands- on experience in coating line operations, lamination, and surface treatments , etc

Location = Kim , Surat

CTC 10-15 LPA Bachelor accommodation

Kindly Share updated Resume asap - Contact Person : Divya

Leading Textile Based Industry - SURAT KIM Location

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
+ Provide strategy, oversight and leadership in support of the APQR run the business activities including document authoring, coordination of review and comments resolution, approval, for both site and End to End APQRs.
+ Ensure execution and performance of run the business and strategic initiatives associated to APQR's continuously improve to meet compliance needs and business priorities.
+ Support health and performance of APQR program in compliance with procedural guidelines and requirements.
+ Ensure on time execution of the APQR program in accordance with the published schedule.
+ Manage stakeholder needs in balance to priorities and execution of the APQR program, through management of the APQR team
+ Manage events associated to findings of compliance gaps, inspectional observations and deviation from global processes.
+ Liaison with the business as the subject-matter expert to ensure accurate APQR content and compliance with health authority regulations and expectations and BMS procedures.
+ Provide leadership and coaching in relation to contemporary knowledge of current industry trends, standards, and methodologies as it relates to APQR.
+ Manage risk and uncertainty, and to anticipate the need for and implement contingency plans to ensure on time delivery of APQR documents.
+ Provide strategy, oversight and leadership in support of the APMC run the business activities including regulatory filing and change control reference data updates, master data maintenance, and data reviews/approvals for products released in SAP Batch Release Hub.
+ Lead team to meet goals while resolving complex issues
+ Develop, adjust, and monitor key performance indicators to identify and mitigate risk to business objectives.
+ Monitor trends to develop continuous improvement objectives and revised contingency plans (as required)
+ Collect metrics to identify trends and take appropriate action.
+ Communicate up to date status to impacted business units
**Qualifications & Experience**
+ Demonstrated quality leadership, organization, and communication skills.
+ Ability to lead a team in a global matrix environment.
+ Understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes, preferred.
+ Experience in a GMP Quality role required.
+ Working knowledge of conducting and compiling APQRs.
+ Prior experience with navigating multiple Quality Management systems.
+ Experience with commercial change control processes.
+ Demonstrated tactical thinking capability with strong project management skills and ability to focus on execution of strategic decisions.
+ Ability to build strong relationships across the organization by being transparent, reliable, and delivering on commitments.
+ Ability to provide innovative ideas, align and make decisions balancing speed, quality, and risk.
+ Education/Experience/ Licenses/Certifications: Minimum of a Bachelor's degree in a Natural Science, Pharmacy, Engineering, or other Healthcare-related field.
+ Minimum 10+ years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated leadership in Quality Compliance or Operations preferred.
+ Minimum 2 + years of people management experience
+ Requires availability during core US and EU hours
+ Fluent in English, with proven professional working proficiency in English for reading, writing and speaking, including the ability to deliver clear and articulate presentations
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :01:00.035 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.