4,197 Contract Compliance jobs in India

Job Title

Associate, APAC CCOR Governance

Short description 

Support APAC CCOR (Compliance, Conduct and Operation Risk) initiatives and departmental strategies.

Posting description

Join our dynamic APAC CCOR Governance Team and play a pivotal role in delivering strategic objectives. As an Associate, you'll engage with senior stakeholders and gain insights into managing CCOR in a global financial institution.

As an Associate in the APAC CCOR Governance Team, you will take responsibility for key initiatives and support our communication strategy. You will work closely with locations, Lines of Business (LOB), horizontal and regional CCOR teams. The role presents an exciting opportunity to interact with senior stakeholders and gain insight into the management of CCOR in a complex global financial institution.

Job responsibilities

Participate in strategic project management, data analysis, and innovation agenda roll-out driven by business needs.

Gather, synthesize, and analyze data to prepare strategic presentations providing insights, identifying issues, and proposing recommendations for APAC CCOR Senior Management.

Centrally manage information flows for key issues and escalations; prepare reports for governance and oversight forums.

Project manage departmental initiatives and strategies by coordinating efforts across teams, managing timelines, and ensuring alignment with organizational goals

Identify opportunities to deploy process changes, system enhancements, business productivity, efficiency tools, and automation.

Lead and govern the Innovation and Automation agenda, including identifying opportunities for AI integration and new technology adoption. 

Required qualifications, capabilities, and skills

Bachelor’s Degree preferably in Information Systems, Business Administration, Finance or related field.

A minimum of 6 years of Compliance or other related experience, such as Risk management, Audit, or similar Control-related experience.

Exceptional project management abilities, including planning timelines, communicating requirements, providing regular updates, and ensuring timely execution.

Proficient in written and verbal communication, with the ability to accurately edit information for Senior Management and effectively articulate initiatives.

Strong analytical skills and attention to detail, including a strong control focus.

Collaborative team player with cultural sensitivity and the ability to work effectively across regions.

Mature, motivated, energetic self-starter who takes ownership and works independently.

Adaptable and responsive to requests in a fast-paced environment; capable of multitasking and meeting deadlines efficiently.

Applied knowledge in solution development using data analytical and visualization tools (., Tableau, QlikView, Alteryx, Cognos).

High ethical standards and integrity in managing confidential information.

Preferred qualifications, capabilities, and skills

Proficiency in analyzing large data sets, summarizing findings, and recommending feasible solutions

Demonstrated track record in delivering Workflow/Automation solutions (., Python, Alteryx, UiPath).

Ability to develop specialized skillsets for conducting in-depth analysis.

Strong interest in the Business Management / Governance area and aspiration for career growth within the team to become Vice President.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all.

**About EY GDS**

Global Delivery Services (GDS) is a dynamic and truly global delivery network. Across our six locations, we work with teams from all EY service lines, geographies and sectors, and play a vital role in the delivery of the EY growth strategy.

We operate from six countries and sixteen cities:

- Argentina (Buenos Aires)
- China (Dalian)
- India (Bangalore, Chennai, Gurgaon, Hyderabad, Kochi, Kolkata, Mumbai, Noida, Trivandrum)
- Philippines (Manila)
- Poland (Warsaw and Wroclaw)
- UK (Manchester, Liverpool)

**Careers in EY Global Delivery Services**

Join a team of over 50,000 people, working across borders, to provide innovative and strategic business solutions to EY member firms around the world.

**Join one of our dynamic teams**

From accountants to coders, we offer a wide variety of fulfilling career opportunities that span all business disciplines

**Your career in Consulting can span across these technology areas/ services lines**:
Digital Technologies: We are a globally integrated digital architecture and engineering team. Our mission is to deliver tailored, custom-built end to end solutions to our customers that are Digital, Cloud Native and Open Source. Our skills include Experience design, UI development, Design Thinking, Architecture & Design, Full stack development (.Net/ Java/ SharePoint/ Power Platform), Emerging Technologies like Block Chain, IoT, ARVR, Drones, Cloud and DevSecOps. We use industrialized techniques, built on top of agile methods utilizing our global teams to deliver end to end solutions at best unit cost proposition.

Testing Services: We are the yardstick of quality software product. We break something to make the product stronger and successful. We provide entire gamut of testing services including Busines / User acceptance testing. Hence this is a team with all round skills such as functional, technical and process.

Data & Analytics: Data and Analytics is amongst the largest and most versatile practices within EY. Our sector and domain expertise combined with technical skills in data, cloud, advanced analytics and artificial intelligence differentiates us in the industry. Our talented team possesses cross-sector and cross-domain expertise and a wide array of skills in Information Management (IM), Business Intelligence (BI), Advance Analytics (AA) and Artificial Intelligence (AI)

Oracle: We provide one-stop solution for end-to-end project implementation enabled by Oracle and IBM Products. We use proven methodologies, tools and accelerators to jumpstart and support large Risk and Finance Transformation. We develop solutions using various languages such as SQL or PL/ SQL, Java, Java Script, Python, IBM Maximo and other Oracle Utilities. We also provide consulting services for streamlining the current reporting process using various Enterprise Performance Management tools.

Banking and Capital Market Services: Banking and Capital Market Services companies are transforming their complex tax and finance functions with technologies such as AI and ML. With the right blend of core competencies, tax and finance personnel will shift to data, process and technology skills to service global clients on their Core Banking Platforms and support their business / digital transformation like Deposit system replacements, lending / leasing modernization, Cloud-native architecture (Containerization) etc.

Wealth and Asset Management: We help our clients thrive in a transformative age by providing innovative services to global and domestic asset management clients to increase efficiency, effectiveness and manage the overall impact on bottom line profitability by leveraging the technology, data and digital teams. We do many operational efficiency programs and Technology Enabled Transformation to re-platform their front and Back offices with emerging technologies like AI, ML, Blockchain etc.

Insurance Transformation: The current changing Macroeconomic trends continue to challenge Insurers globally. However, with disruptive technologies - including IoT, autonomous vehicles, Blockchain etc, we help companies through these challenges and create innovative strategies to transform their business through technology enabled transformation programs. We provide end to end services to Global P&C (General), Life and Health Insurers, Reinsurers and Insurance brokers.

Cyber Security: The ever-increasing risk and complexity surrounding cybersecurity and privacy has put cybersecurity at the top of the agenda for senior management, the Board of Directors, and regulators. We help our clients to understand and quantify their cyber risk, priori

**Primary** **Job** **Function:**
To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.
**Core Job Responsibilities:**
**Regulatory Submissions and compliance**
+ Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
+ Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
+ Ensure timely submissions and approvals for all regulatory filings.
+ Evaluate technical and scientific data for regulatory submissions.
+ Liaise with health authorities for inspections, clarifications, and approvals.
+ Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
**Product & Business Support**
+ Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
+ Provide regulatory support for internalization and externalization of products.
+ To provide site CMC documents to international business team to support export registration.
**Documentation & Quality Oversight**
+ Maintain and update regulatory databases, trackers, licenses, and approvals.
+ Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
+ Evaluate and approve site change controls and Change Request evaluation forms.
+ Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
**Tender Certificates**
+ To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
+ Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
**Governance, SOPs & Training**
+ Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
+ Deliver training on GMP, regulatory updates, and SOPs at the site level.
+ Approve SCNs from Corporate QA and review reports from regulatory authorities.
**Additional Responsibilities**
+ Complete assigned trainings on time
+ Perform other duties as assigned by the Regulatory Affairs leadership.
+ Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
**Position Accountability/Scope:**
+ ·Responsible for all regulatory activities for the manufacturing site mainly LL sites.
+ ·Ensures site compliance with applicable national regulations and Abbott standards.
+ Supports business continuity through proactive regulatory planning and execution.
**Minimum Education:**
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
**Minimum Experience/Training Required:**
+ **Manager:** Minimum 08 - 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
+ Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

Primary Job Function:

To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.

Core Job Responsibilities:

Regulatory Submissions and compliance

Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA

Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.

Ensure timely submissions and approvals for all regulatory filings.

Evaluate technical and scientific data for regulatory submissions.

Liaise with health authorities for inspections, clarifications, and approvals.

Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.

Product & Business Support

Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.

Provide regulatory support for internalization and externalization of products.

To provide site CMC documents to international business team to support export registration.

Documentation & Quality Oversight

Maintain and update regulatory databases, trackers, licenses, and approvals.

Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.

Evaluate and approve site change controls and Change Request evaluation forms.

Provide working standards/specifications and CoAs to regulatory authorities and internal teams.

Tender Certificates

To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.

Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.

Governance, SOPs & Training

Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.

Deliver training on GMP, regulatory updates, and SOPs at the site level.

Approve SCNs from Corporate QA and review reports from regulatory authorities.

Additional Responsibilities

Complete assigned trainings on time

Perform other duties as assigned by the Regulatory Affairs leadership.

Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.

Position Accountability/Scope:

·Responsible for all regulatory activities for the manufacturing site mainly LL sites.

·Ensures site compliance with applicable national regulations and Abbott standards.

Supports business continuity through proactive regulatory planning and execution.

Minimum Education:

B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

Minimum Experience/Training Required:

Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.

Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.

Description

We are seeking a highly skilled Regulatory Compliance professional to join our team in India. The ideal candidate will be responsible for ensuring that our organization adheres to all regulatory requirements and standards, thereby minimizing risk and promoting ethical practices.

Responsibilities

• Ensure compliance with all relevant regulatory requirements in India.
• Review and interpret new and existing regulations and provide guidance to internal teams.
• Conduct risk assessments and compliance audits to identify potential compliance gaps.
• Develop and implement compliance policies and procedures to meet regulatory standards.
• Prepare and submit necessary reports to regulatory bodies as required.
• Provide training and support to staff on compliance matters.
• Collaborate with internal departments to ensure compliance is integrated into business processes.

Skills and Qualifications

• Bachelor's degree in Law, Business Administration, or a related field.
• 5-15 years of experience in regulatory compliance, preferably in the financial services or healthcare sectors.
• Strong understanding of Indian regulatory frameworks and compliance requirements.
• Excellent analytical and problem-solving skills.
• Ability to interpret complex regulations and provide clear guidance.
• Strong communication and interpersonal skills for collaboration with various stakeholders.
• Proficiency in compliance management software and tools.
• Detail-oriented with strong organizational skills.

Education
Master of Public Administration (MPA), Master of Library & Information Science (MLIS), Doctor of Public Health (DrPH), Masters in Technology (M.Tech/M.E), PGDM, Doctor of Psychology (Psy. D./D. Psych.), Bachelor Of Computer Application (B.C.A), Bachelors of Law (B.L/L.L.B), Doctor of Physical Therapy, PGP, Bachelor of Homeopathic Medicine and Surgery (BHMS), Master of Law (M.L/L.L.M), MBBS, Doctor of Medicine (M.D/M.S), Bachelor of Business Administration (B.B.A), Doctor of Optometry, Doctor of Business Administration (DBA), Master OF Business Administration (M.B.A), Post Graduate Diploma in Computer Applications (PGDCA), Master in Computer Application (M.C.A), Bachelor of Dental Surgery (B.D.S), Post Graduate Programme in Management for Executives (PGPX), Doctor of Pharmacy (PharmD), Doctor of Veterinary Medicine (DVM), Bachelor Of Technology (B.Tech/B.E), Bachelor of Ayurvedic Medicine and Surgery (BAMS), Doctor of Dental Surgery/Medicine (DDS/DMD), Doctor of Nursing Practice (DNP)
Skills Required
regulatory knowledge, Risk Assessment, Compliance Reporting, policy development , Data Analysis, Legal Research, Process Improvement, Stakeholder Engagement, Project Management

The opportunity

We’re looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. 

Gather and analyse business requirements related to LIMS functionality and enhancements. 

Analyse laboratory workflows and processes to recommend and implement LIMS solutions. 

Translate business needs into functional specifications and system configurations. 

Configure, test, and validate LIMS functionalities to meet business needs. 

Conduct impact analysis and risk assessments for LIMS changes and enhancements. 

Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. 

Participate in business process mapping and workflow optimization to enhance LIMS utilization.

Provide input on LIMS enhancements and new feature development to improve system performance. 

Assist in troubleshooting, identifying, and resolving LIMS-related issues. 

Conduct user training sessions and provide end-user support.

Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. 

Identify opportunities for automation and process improvement within laboratory operations using LIMS. 

Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS.

Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime.

Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. 

Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. 

Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc.

Stay up to date with new LIMS technologies, trends, and best practices. 

Ensure system security, access control, and compliance with IT policies. 

Provide ongoing support and maintenance for LIMS applications. 

Engage in change management processes and drive adoption of new system functionalities. 

Work with vendors and third-party providers to Configure, implement upgrades and enhancements. 

Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines

Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.

Review status updates and prepare management presentations.

Actively contribute to improving operational efficiency on projects & internal initiatives.

Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.

Contribute to performance feedback for staff

Foster teamwork and a positive learning culture 

Understand and follow workplace policies and procedures

Training and mentoring of project resources

Cross skill and cross train the team members as per the business requirements 

Skills and attributes for success

Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. 

Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. 

Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. 

Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. 

Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. 

Proficiency in LIMS software (, LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms).

Knowledge of system integration with ERP, MES, or other enterprise applications. 

Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. 

Hands-on experience in master data configuration within LIMS platforms. 

Experience in system validation, testing, and documentation. 

Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization

Understanding of relational databases and SQL queries. 

Experience with scripting or automation tools for LIMS is a plus. 

Understanding of API integrations, web services, and middleware solutions for LIMS. 

Ability to troubleshoot system and data issues efficiently. 

Strong problem-solving and analytical skills. 

Excellent communication and stakeholder management abilities. 

Ability to work independently and as part of a cross-functional team. 

Strong attention to detail and commitment to data integrity. 

Adaptability to dynamic business and regulatory environments. 

Demonstrated track record in project management, governance, and reporting

Exposure to Data Integrity requirements and other applicable regulations

Knowledge of Incident Management, Change Management.

Prior experience of supporting Audits / Inspections

To qualify for the role, you must have

(Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries.

Good interpersonal skills; Good written, oral and presentation skills

Ideally, you’ll also have

Information Security (ISO 27001) or Risk Management certifications 

LIMS admin certification or Equivalent

Certified Scrum Master (CSM) or Equivalent (Preferred but not required).

What we look for

A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.

An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.

Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

Support, coaching and feedback from some of the most engaging colleagues around

Opportunities to develop new skills and progress your career

The freedom and flexibility to handle your role in a way that’s right for you

EY | Building a better working world 

EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you'll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

We're looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

• Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
• Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
• Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions.
• Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
• Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
• Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
• Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
• Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
• Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
• Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
• Review status updates and prepare management presentations.
• Actively contribute to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
• Contribute to performance feedback for staff
• Foster teamwork and a positive learning culture
• Understand and follow workplace policies and procedures
• Training and mentoring of project resources
• Cross skill and cross train the team members as per the business requirements

Skills and attributes for success

• Prior experience of leading quality and compliance projects in Regulatory Compliance.
• Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
• Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC
• Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization
• Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
• Demonstrated track record in project management, governance, and reporting
• Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc.
• Exposure to Data Integrity requirements and other applicable regulations
• Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures
• Prior experience of supporting Audits / Inspections
• Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance
• Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
• Hands on experience of preparing validation deliverables for software implementation projects
• Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,

To qualify for the role, you must have

• B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies
• Good interpersonal skills; Good written and presentational skills

Ideally, you'll also have

• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
• Information Security or Risk Management certifications

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

Skills Required
Lims, Sap, RIMS, Hipaa

EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Manager

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Manager actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you'll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team, identify automation opportunities and drive internal initiatives.

The opportunity

We're looking for Manager with expertise in Computer System Validation and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

• Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
• Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
• Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
• Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
• Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
• Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
• Identify opportunities in existing accounts to cross-sell other EY services.
• Planning and monitoring of the project deliverables from the team.
• Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
• Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
• Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
• Regular status reporting to the Senior Managers, Partners, Directors and onsite coordinators.
• Actively contribute to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
• Demonstrate flexibility to travel to the customer locations on need basis
• Conduct performance reviews and contribute to performance feedback for staff and senior staff
• Foster teamwork, quality culture and lead by example
• Understand and follow workplace policies and procedures
• Training and mentoring of project resources
• Participate in the organization-wide initiatives
• Lead practice initiatives and portfolios
• Market trend +Digital trends.
• Cross skill and cross train the team members as per the business requirements

Skills and attributes for success

• Quality & Compliance managed services and Consulting experience in of Life Sciences Domain.
• Has worked in executing the Validation Deliverables in software implementation projects
• Strong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
• Strong knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
• Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts.
• Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization.
• Versed with SOP documentation, analysing the work instructions, user manuals
• Strong knowledge of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems
• Strong understanding of Data Integrity requirements
• Governance and reporting
• Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
• Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
• Has supported Audits / Inspections
• Sound domain knowledge in Pharmaceutical industry in the areas of Quality and Compliance
• Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems

To qualify for the role, you must have

• B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance companies
• Good interpersonal skills; Good written and presentational skills
• At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations
• Experience in managing team and solution designing

Ideally, you'll also have

• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
• Information Security or Risk Management certifications
• Project Management

Skills Required
Lims, Sap

Your key responsibilities

• Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. 
• Gather and analyse business requirements related to LIMS functionality and enhancements. 
• Analyse laboratory workflows and processes to recommend and implement LIMS solutions. 
• Translate business needs into functional specifications and system configurations. 
• Configure, test, and validate LIMS functionalities to meet business needs. 
• Conduct impact analysis and risk assessments for LIMS changes and enhancements. 
• Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. 
• Participate in business process mapping and workflow optimization to enhance LIMS utilization.
• Provide input on LIMS enhancements and new feature development to improve system performance. 
• Assist in troubleshooting, identifying, and resolving LIMS-related issues. 
• Conduct user training sessions and provide end-user support.
• Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. 
• Identify opportunities for automation and process improvement within laboratory operations using LIMS. 
• Master Data Design Configuration
• Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets.
• Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS.
• Maintain data integrity, consistency, and version control across the system. 
• Implement changes and updates to LIMS master data in alignment with business and regulatory needs. 
• Collaborate with cross-functional teams to ensure accurate data migration and system integration. 
• Troubleshoot and resolve issues related to master data configuration and system functionality. 
• Work on optimizing data structures and database management within LIMS. 
• Configurations & Customizations
• Develop, customize, and implement LIMS applications to meet laboratory and business requirements.
• Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. 
• Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. 
• Design and optimize databases for efficient storage and retrieval of laboratory data. 
• Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. 
• Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. 
• Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. 
• Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. 
• Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc.
• Stay up to date with new LIMS technologies, trends, and best practices. 
• Ensure system security, access control, and compliance with IT policies. 
• Provide ongoing support and maintenance for LIMS applications. 
• Engage in change management processes and drive adoption of new system functionalities. 
• Work with vendors and third-party providers to Configure, implement upgrades and enhancements. 
• Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines
• Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
• Review status updates and prepare management presentations.
• Actively contribute to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
• Contribute to performance feedback for staff
• Foster teamwork and a positive learning culture 
• Understand and follow workplace policies and procedures
• Training and mentoring of project resources
• Cross skill and cross train the team members as per the business requirements 

Skills and attributes for success

• Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. 
• Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. 
• Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. 
• Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. 
• Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. 
• Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms).
• Knowledge of system integration with ERP, MES, or other enterprise applications. 
• Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. 
• Hands-on experience in master data configuration within LIMS platforms. 
• Experience in system validation, testing, and documentation. 
• Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization
• Understanding of relational databases and SQL queries. 
• Experience with scripting or automation tools for LIMS is a plus. 
• Understanding of API integrations, web services, and middleware solutions for LIMS. 
• Ability to troubleshoot system and data issues efficiently. 
• Strong problem-solving and analytical skills. 
• Excellent communication and stakeholder management abilities. 
• Ability to work independently and as part of a cross-functional team. 
• Strong attention to detail and commitment to data integrity. 
• Adaptability to dynamic business and regulatory environments. 
• Demonstrated track record in project management, governance, and reporting
• Exposure to Data Integrity requirements and other applicable regulations
• Knowledge of Incident Management, Change Management.
• Prior experience of supporting Audits / Inspections

To qualify for the role, you must have

• B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries.
• Good interpersonal skills; Good written, oral and presentation skills

Ideally, you'll also have

• Information Security (ISO 27001) or Risk Management certifications 
• LIMS admin certification or Equivalent
• Certified Scrum Master (CSM) or Equivalent (Preferred but not required).

Skills Required
It Security, Lims, Csm