JOB PURPOSE
Provide independent Quality Assurance oversight of clinical development, and outsourced GCP activities to ensure compliance with regulatory requirements, ICH-GCP, and SPARC quality standards. The role leads risk-based quality initiatives, audits, quality systems, and inspection readiness activities to support compliant and inspection-ready operations across product development programs.

KEY ACCOUNTABILITIES
• Independently manage GCP quality activities and provide QA oversight across clinical development programs.
• Develop, implement, and oversee the annual risk-based QA audit program covering investigator sites, CROs, laboratories, Vendors/Service Providers, depots, and internal quality systems.
• Plan and conduct GCP audits, ensuring timely reporting, escalation of critical findings, and effective CAPA implementation and closure.
• Provide independent QA oversight for clinical development programs and outsourced GCP service activities.
• Lead quality review and approval of SOPs, quality records, deviations, CAPAs, risk assessments,



and other quality system documentation.
• Serve as a quality advisor to cross-functional teams, providing strategic guidance on GCP, regulatory compliance, inspection readiness, and quality risk management.
• Support and lead activities related to health authority inspections, sponsor audits and due diligence assessments.
• Ensure oversight of eTMF, essential records, and other GCP records to maintain inspection readiness.
• Monitor quality metrics and compliance trends, identify areas for continuous improvement, and implement actions to strengthen the QMS.
• Manage relationships with CROs, laboratories, and other service providers to ensure quality and compliance expectations are met.
• Mentor and provide quality guidance to cross-functional teams and junior personnel, fostering a culture of quality, compliance, and continuous improvement.
• Collaborate effectively with Clinical Operations, Regulatory Affairs, Clinical Sc

📌 Manager - QA (GCP) (Mumbai)
🏢 Sun Pharma Advanced Research Company
📍 Mumbai