Group Lead – Clinical QA Job At Syngene
Syngene International Ltd. is hiring an experienced Group Lead – Clinical QA (GCP) in Bengaluru. This senior leadership Clinical Job role is ideal for professionals with strong expertise in Good Clinical Practice (GCP), clinical audits, and regulatory compliance, who are ready to lead quality systems and ensure inspection readiness across clinical research operations. Graduates seeking M Pharma jobs and want to start their career with Syngene careers can apply now.
Clinical Job Details
- Job Title: Group Lead – Clinical
- Location: Bengaluru, Karnataka, India – 560100
About the Company – Syngene International Ltd.
Syngene is a leading contract research, development, and manufacturing organization (CRDMO) supporting global pharmaceutical, biotechnology, and life sciences companies. Known for its strong quality culture and scientific excellence, Syngene focuses on innovation, regulatory compliance, and ethical research practices across discovery, development, and manufacturing services. This Clinical Job role plays a significant role in the company.
Key Responsibilities
- Plan, schedule, and lead GCP QA audits for bioequivalence studies, clinical trials (Phase I–III), and clinical data management
- Develop risk-based audit plans focusing on subject safety, ethics, protocol adherence, and regulatory compliance
- Conduct and oversee study-based, process, site, system, and database audits
- Review clinical data and documents submitted to sponsors and regulatory authorities
- Manage and mentor GCP QA auditors, ensuring audit quality and consistency
- Reviewing audit reports and evaluate CAPA effectiveness is essential for this Clinical Job role
- Collaborate with clinical operations to resolve internal and external audit findings
- Lead investigations into GCP breaches, misconduct, and non-compliance
- Perform or oversee root cause analysis (RCA) and CAPA implementation
- Conduct vendor audits (onsite and remote) and monitor vendor compliance
- Oversee TMF audits, system audits, due diligence audits, and 21 CFR Part 11 audits
- Track and report QA metrics, study quality trends, and compliance indicators
- Support regulatory agency inspections and inspection readiness activities
Educational Requirements
-
M.Pharm
Skills Required for this Clinical Job
- Strong experience in GCP Quality Assurance audits
- In-depth knowledge of clinical research, BE/BA studies, and drug development
- Thorough understanding of ICH, USFDA, EMA, MHRA, and global GCP guidelines
- Expertise in CAPA, RCA, inspection readiness, and audit management
- Strategic thinking and decision-making in a matrix organization
- Strong communication and leadership skills
- Graduates seeking M Pharma jobs and want to start their career with Syngene careers can apply now.
