Quality Management System Manager

Manager - QMS Roles and Responsibilities

• Lead large-scale QMS transformation programs across multiple regions and business units.
• Define project scope, objectives, timelines, and deliverables aligned with organizational goals.
• Manage project plans, risks, issues, dependencies, and budgets.
• Ensure successful delivery within scope, time, and cost constraints.

Stakeholder Management

• Act as the primary point of contact for senior leadership and client stakeholders (West Pharma).
• Facilitate governance meetings, steering committees, and status reporting.
• Build strong relationships across Quality, IT, and business teams.

QMS Transformation & Compliance

• Ensure compliance with global regulatory standards such as FDA (21 CFR Part 11), GxP, ISO standards (e.g., ISO 13485).
• Drive implementation or enhancement of QMS platforms (e.g., TrackWise, Veeva Vault QMS, etc.).
• Support process harmonization, standardization, and digital transformation initiatives.

Change Management

• Lead organizational change management activities.
• Drive user adoption, training, and communication strategies.
• Manage resistance and ensure smooth transition to new systems/processes.

Cross-functional Collaboration

• Work closely with IT teams for system implementation and integration.
• Collaborate with Quality and Regulatory teams for validation and compliance.
• Coordinate with vendors and third-party partners.

Risk & Quality Management

• Identify, assess, and mitigate project risks.
• Ensure quality of deliverables and adherence to project governance standards.
• Oversee validation documentation (IQ/OQ/PQ) where applicable.

About you

• Experience working with global stakeholders and distributed teams.
• Strong leadership, communication, and stakeholder management skills.
• Knowledge of Agile and/or hybrid project methodologies.
• Exposure to digital transformation and data-driven quality systems.
• Strategic thinking and execution.
• Strong problem-solving and decision-making.
• Excellent communication and influencing skills.
• Ability to manage ambiguity and complex environments.

Must have

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
• 10–15+ years of project/program management experience.
• Strong experience in QMS transformation within Pharma/Medical Devices.
• Proven track record of delivering large-scale transformation programs.
• Deep understanding of regulatory frameworks (FDA, GxP, ISO).
• Experience with QMS tools (TrackWise, Veeva Vault, etc.).
• Overall experience: 10-15 years.
• Minimum 5-year experience with Medical Devices Regulatory Affairs.
• Minimum 3-year experience leading projects/teams; 5-year or more experience in respective area of expertise.
• RAC (Regulatory Affairs Certification) Certified is a plus.
• PMP certification is a plus.

Your impact

• Industry experience and knowledge of Medical device/IVD/SaMD/ Drug-device combination products related regulatory affairs.
• Experience in relevant regulatory subjects in medical device manufacturing organizations, professional services organizations, healthcare delivery organizations, or in consultancies serving those organizations.
• Experience interfacing effectively with domestic and international regulatory agencies.
• In depth knowledge of medical device regulations- US FDA, EU MDD, EU MDR & other country specific laws & regulations like TGA, NMPA, Indian regulations etc.
• Ability to manage small to big sized projects: organized, independent, and results-oriented.
• Superb analytical and excellent communication skills, strong team ethics, and attention to detail.
• Strong influencing and communication skills and the ability to comprehend complex regulatory topics and disseminate information to a varied audience.

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.