Clinical Research Job at Syngene | Life Sciences | Apply Now
Syngene International Ltd. is looking for a high-caliber professional to fill the role of Group Leader GCP – QA (Clinical) in Bangalore. This clinical research job is a “Thought Leader” level position, designed for experts capable of scaling GCP Quality Systems and leading a team of auditors to ensure global regulatory excellence. A Syngene career offers the opportunity to join one of India’s leading integrated R&D services organizations, supporting Phase I–III clinical trials and bioequivalence studies for global sponsors.
- Job Position: Group Leader GCP – QA
- Location: Bangalore, India.
- Division: Translational & Clinical Research (T&CR)
About the Company
Syngene is an Equal Opportunity Employer (EEO) committed to diversity and inclusion across all characteristics, including race, gender, and disability status. The company values Excellence, Integrity, and Professionalism, providing a safety-first culture where data integrity and scientific capability are paramount.
Key Responsibilities & Leadership Scope
The Group Leader is responsible for independent oversight of the GCP Quality System, ensuring Syngene remains audit-ready for national and international health authorities.
- Audit Management: Schedule and conduct GCP QA audits covering Bioequivalence studies, Clinical Trials (Phase I-III), and Clinical Data Management.
- Risk-Based Planning: Develop audit plans focusing on ethical conduct, subject safety, medical care, and protocol adherence.
- Team Oversight: Manage a team of GCP QA auditors, reviewing their reports and assessing CAPA (Corrective Action Preventative Action) plans to ensure they meet SOP and regulatory standards.
- Vendor & Investigative QA: Lead onsite/remote vendor audits and manage investigations into potential misconduct or serious GCP breaches.
- Metrics & Reporting: Perform Root Cause Analysis (RCA) and maintain quality metrics and trends for reporting to the GCP QA Head of Department.
- Inspection Readiness: Assist management in the hosting and readiness for regulatory agency inspections (USFDA, EMA, MHRA, etc.).
Eligibility & Skills Profile
This Biotechnology Job requires a profound understanding of the clinical development lifecycle and global regulatory frameworks.
- Education: M.Sc. / M.Tech in Life Sciences or Biotechnology.
- Technical Knowledge: Sound expertise in BE/BA studies, drug development, pharmacology, and 21 CFR Part 11 audits.
- Regulatory Mastery: Thorough knowledge of ICH-GCP, USFDA, EMA, and MHRA guidelines.
- Core Competencies: Strategic thinking, excellence in decision-making within a matrix environment, and a commitment to EHS (Environment, Health, and Safety) protocols.
Advancing your Syngene career as a Group Leader in GCP QA places you at the forefront of global clinical compliance. This clinical research job is ideal for seasoned professionals with a Biotechnology Job background who are ready to drive quality excellence in a “Thought Leader” capacity. If you possess the required expertise in ICH-GCP and international audits, apply now to join Syngene’s world-class clinical team.
