Quality Management System Manager

Who are we?

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com

What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?

We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.

We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.

If this excites you, then apply below.

Job Title: Manager - QMS

Roles and Responsibilities:

Program & Project Leadership

• 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

• Drive implementation or enhancement of QMS platforms (e.g., TrackWise, Veeva Vault QMS, etc.)

• Ensure compliance with global regulatory standards such as:

o FDA (21 CFR Part 11)

o GxP

o ISO standards (e.g., ISO 13485)

• 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:

• PMP / PRINCE2 certification

• 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

Key Competencies

• 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.)
• Bachelor’s or master's degree in engineering/life science;
• 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
• Good presentation skills
• 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.