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 QA / Pharmaceutical R&D / Clinical Research Compliance
We are hiring a Manager – R&D Quality GCP QA to lead Good Clinical Practice (GCP) quality assurance oversight, audit management, compliance governance, CAPA effectiveness, regulatory inspection readiness, and quality systems development for in-house and outsourced clinical/BA-BE studies.
This role is ideal for professionals with deep expertise in GCP quality assurance, clinical audits, CRO/vendor qualification, regulatory inspection support, SOP governance, CAPA management, and clinical compliance leadership.
The ideal candidate will strengthen quality systems, ensure inspection readiness, and maintain regulatory compliance across clinical research operations.
Lead development, implementation, harmonization, and continuous improvement of clinical quality systems.
Responsibilities include:
Ensure systems align with:
Conduct independent GCP audits for in-house and outsourced clinical programs.
Audit scope includes:
Objective:
Perform:
Assess:
Support vendor governance and qualification decisions.
Lead end-to-end CAPA oversight including:
Manage CAPAs arising from:
Provide GCP QA oversight for study documentation including:
Ensure compliance with:
Support regulatory inspection preparedness for clinical programs.
Responsibilities:
Collaborate with:
Provide quality support for:
Maintain oversight for compliance with:
Advise teams on evolving regulatory expectations.
Drive harmonization of QA systems across:
Improve consistency, efficiency, and inspection readiness.
Stay updated on:
Translate regulatory updates into actionable quality improvements.
Lead and mentor team members through:
Support both direct and indirect team capability building.
Minimum:
Preferred:
10+ years of GCP environment experience
Including:
Minimum 6+ years in Quality Assurance
Preferred backgrounds:
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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