Senior Manager - Corporate Quality Compliance

As a Senior Manager in the Global Actions Management sub-function of Corporate Quality Compliance at Sunpharma, your main responsibility will be to ensure the assessment and derivation of global actions based on regulatory inspection citations, 483s, warning letters, and internal learnings. This will involve tasks such as reviewing regulatory guidance, existing site practices, drafting global action recommendations, preparing reference procedures, and finalizing recommendations in collaboration with the global action committee and stakeholders. You will also be responsible for issuing and approving global actions in Trackwise, coordinating with sites for implementation, reviewing site action closure, circulating global action status to stakeholders, and facilitating compliance calls to share internal and external learnings. Tracking identified gaps across sites, maintaining a database for regulatory inspections at SUN Pharma, reviewing draft responses to inspection observations, and ensuring the trend analysis of Sun site regulatory inspection observations will be crucial aspects of your role. Additionally, you will be expected to handle all other duties as assigned by the Head of Corporate Quality Compliance and CQA. The role may require an estimated travel of approximately 30% and the following qualifications and skills: Educational Qualification: M.SC / M. Pharm Specific Certification: Not specific Skills: Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile) Experience: Minimum 15 years If you are a detail-oriented professional with a strong background in quality compliance, regulatory affairs, and global actions management, this Senior Manager position at Sunpharma in Vadodara could be the next step in your career journey.,