Group Leader – Clinical GCP Quality Assurance (QA)
Location: Bangalore, Karnataka, India
Experience Required: Senior-level experience in Clinical QA/GCP audits
Division: Essential Functions
Company: Syngene International Ltd.
About Syngene:
Syngene International Ltd. is a global, innovation-led contract research, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. With a 4,000+ strong scientific workforce, Syngene partners with leading global organizations to enhance R&D productivity, accelerate time-to-market, and ensure regulatory compliance.
Role Overview:
The Group Leader – Clinical GCP QA will lead Syngene’s team of GCP QA auditors, overseeing study-based audits, process audits, clinical and safety database audits, and vendor assessments. This leadership role ensures that clinical operations (Bioequivalence studies, Phase I-III clinical trials, and Clinical Data Management) comply with national and international regulatory standards and are inspection-ready. The role requires strong judgment, strategic thinking, and the ability to communicate professionally across functional and geographic teams.
Key Responsibilities:
Develop and execute risk-based audit plans for clinical operations, focusing on patient safety, ethical conduct, protocol adherence, and GCP compliance.
Schedule, conduct, or manage resources for audits of clinical trials, Bioequivalence studies, and clinical data management activities.
Provide oversight for GCP QA auditors, ensuring audit reports are complete and corrective actions (CAPA) are effectively implemented.
Collaborate with clinical teams on external audit follow-ups and lessons-learned debriefs for continuous process improvement.
Conduct or oversee vendor audits, root cause analyses (RCA), internal process audits, system audits, TMF audits, and 21 CFR Part 11 compliance reviews.
Lead investigations of serious GCP breaches, misconduct, or noncompliance issues, escalating critical findings to GCP QA Head of Department (HOD).
Maintain and report team activity metrics, study quality metrics, and trends to GCP QA HOD.
Support regulatory inspections and ensure ongoing readiness of clinical operations for audits by external agencies.
Educational Qualifications:
M.Sc., M. Pharm., or M. Tech. in Basic Medical Sciences, Life Sciences, or Biotechnology.
Skills & Competencies:
Extensive experience performing and managing Quality Assurance audits in a GCP environment.
Strong technical knowledge of Bioequivalence (BE/BA) studies, clinical research, drug development, and pharmacology.
In-depth understanding of regulatory guidelines, including ICH, USFDA, EMA, and MHRA.
Strategic thinker with excellent judgment, decision-making skills, and the ability to work effectively in a matrix organization.
Strong communication, leadership, and interpersonal skills.
Core Values:
All employees are expected to demonstrate Syngene’s core values consistently:
Excellence – Delivering high-quality outcomes.
Integrity – Upholding ethical and regulatory standards.
Professionalism – Maintaining accountability and collaborative work practices.
Equal Opportunity Employer:
Syngene International Ltd. provides equal employment opportunities to all qualified individuals regardless of age, gender, race, religion, disability, or other legally protected characteristics. Reasonable accommodations are available for qualified individuals with disabilities.
Apply Now:
Submit your CV and cover letter through the Syngene careers portal highlighting your experience in Clinical QA, GCP audits, and regulatory compliance.
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