Manager - QA (GCP)

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 Sciences, Safety/pharmacovigilance, Supply Chain, Data Management, Statistical programming and external partners to support successful product development programs.
• Maintain current knowledge of evolving global regulations, industry best practices, and regulatory expectations relevant to clinical research activities.
• Utilize electronic quality systems and compliance tools, including QMS, LMS, eTMF, IWRS, EDC and audit management systems (e.g., TrackWise, Veeva or equivalent, risk management tools).

EDUCATION & EXPERIENCE

Educational Qualifications

• B. Pharm / M.Sc. / BAMS / BHMS similar Life Sciences degree within a scientific discipline
• Certification in Auditing, Clinical Research or Regulatory Affairs, GCP will be an added advantage

Relevant Experience

• 10-12 years of experience in the pharmaceutical, biotechnology, or Contract Research Organization (CRO) industry, with significant experience in GCP QA, auditing, regulatory compliance, and quality systems.
• Candidates with strong clinical operations experience, including site monitoring and auditing, are also preferred.
• Demonstrated experience conducting audits of investigator sites, laboratories, eTMF systems, vendors, IP depots, and other GCP service providers.
• Experience supporting clinical development programs, including clinical studies activities in India, the US and other regulated markets.
• Hands-on experience in QA review of clinical quality records, deviation investigations, CAPA management, risk assessments, and quality system oversight.
• Demonstrated experience hosting, supporting, and responding to regulatory inspections and sponsor audits, including interactions with CDSCO, US FDA, EMA, MHRA, and other regulatory authorities.
• Experience in qualification, oversight, and performance management of CROs, and other GCP Vendors.
• Experience working on novel drug development programs and collaborating effectively with cross-functional teams including Clinical Operations, Regulatory Affairs, Safety, Medical Affairs, and Supply Chain.
• Ability to apply risk-based quality principles to support audit readiness/continuous improvement initiatives.