Job Title: Manager – R&D Quality GCP QA
Company: Sun Pharma
Location: Vadodara, India
Business Unit: Sun R&D Quality
Employment Type: Full-Time
Industry: Clinical Quality Assurance / GCP Quality / R&D Quality / Clinical Compliance
Sun Pharma is hiring a Manager – R&D Quality GCP QA to lead Good Clinical Practice (GCP) quality assurance, BA/BE audit oversight, CRO qualification, CAPA governance, inspection readiness, and clinical quality systems implementation across in-house and outsourced R&D clinical studies.
This role is ideal for senior clinical quality professionals with expertise in GCP audits, bioavailability/bioequivalence (BA/BE) studies, CRO/vendor qualification, regulatory inspections, CAPA management, and clinical quality systems.
The position plays a strategic role in strengthening compliance, audit readiness, and quality governance across Sun Pharma’s clinical research ecosystem.
Lead development and implementation of quality systems across R&D.
Responsibilities include:
Ensure robust and scalable clinical quality frameworks.
Plan and conduct comprehensive GCP audits.
Audit coverage includes:
Objectives:
Provide QA leadership for:
Ensure studies comply with:
Lead qualification and re-qualification of:
Responsibilities:
Manage end-to-end CAPA quality oversight.
Responsibilities:
Includes CAPAs arising from:
Drive consistency across quality systems.
Responsibilities:
Improve operational consistency and compliance maturity.
Provide GCP QA oversight for creation/review of:
Ensure compliance with:
Support inspection readiness and regulatory interactions.
Responsibilities:
Partner with R&D stakeholders for timely regulatory compliance.
Support:
Ensure timely and scientifically appropriate responses.
Maintain awareness of evolving:
Provide expert guidance on regulatory interpretation and implementation.
Mentor and develop direct/indirect team members.
Responsibilities:
Build a strong clinical quality culture.
Minimum:
Preferred:
10+ years of GCP environment experience
Uttar Pradesh :
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