Quality System Manager

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. 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 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. 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 • Stakeholder Management • Build strong relationships across Quality, IT, and business teams QMS Transformation & Compliance • Drive implementation or enhancement of QMS platforms (e.g., Ensure compliance with global regulatory standards such as: Support process harmonization, standardization, and digital transformation initiatives Change Management • Lead organizational change management activities • Drive user adoption, training, and communication strategies • Work closely with IT teams for system implementation and integration • Collaborate with Quality and Regulatory teams for validation and compliance • Risk & Quality Management • Identify, assess, and mitigate project risks • Ensure quality of deliverables and adherence to project governance standards • PMP / PRINCE2 certification • Strong leadership, communication, and stakeholder management skills • Knowledge of Agile and/or hybrid project methodologies • Exposure to digital transformation and data-driven quality systems 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) ~ Bachelor’s or master's degree in engineering/life science; ~ Minimum 5-year experience with Medical Devices Regulatory Affairs Minimum 3-year experience leading projects/teams; ~RAC (Regulatory Affairs Certification) Certified is a plus ~ PMP certification is a plus 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 Strong influencing and communication skills and the ability to comprehend complex regulatory topics and disseminate information to a varied audience. Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. 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.