Job Title: Group Leader – GCP QA (Clinical)
Location: Bangalore, India
Division: Translational & Clinical Research (T&CR)
Job Level: Thought Leader / Senior Leadership
Employment Type: Full-Time
Syngene International Ltd. is a global contract research, development, and manufacturing organization providing integrated scientific services across pharmaceuticals, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. The organization is committed to scientific innovation, regulatory compliance, and operational excellence, serving leading global clients.
The Group Leader – GCP QA (Clinical) will lead the Clinical Quality Assurance function, managing GCP QA auditors and ensuring compliance with global regulatory standards across bioequivalence, clinical trials (Phase I–III), and clinical data management operations.
Lead and manage the GCP QA auditing team, including study-based, process, site, and database audits.
Develop and implement risk-based audit plans focused on ethical conduct, subject safety, protocol adherence, and regulatory compliance.
Oversee audit execution and reporting, ensuring Corrective and Preventive Actions (CAPA) are adequate and compliant with SOPs and regulations.
Collaborate with clinical operations teams to ensure audit findings are resolved and lessons learned are integrated into continuous improvement practices.
Conduct vendor audits (onsite/remote) and provide follow-up on corrective actions and quality issues.
Lead or assist investigations into serious GCP breaches, misconduct, or noncompliance.
Oversee internal audits, due diligence, system audits, Trial Master File (TMF) audits, and 21CFR Part 11 compliance audits.
Maintain GCP QA metrics, quality trends, and audit documentation; support readiness for regulatory inspections.
Provide guidance on compliance, regulatory guidelines, and best practices to internal stakeholders.
Education: M.Sc., M. Pharm, or M. Tech in Basic Medical Sciences, Life Sciences, or Biotechnology.
Experience: Minimum 8–12 years in clinical quality assurance or clinical operations, with experience managing QA audits in a GCP environment.
Technical Expertise:
GCP audits for Bioequivalence studies, Phase I–III clinical trials, and clinical data management.
Strong knowledge of regulatory guidelines: ICH, US FDA, EMA, MHRA.
Clinical research, drug development processes, and basic pharmacology understanding.
Leadership Skills: Strategic thinker with decision-making experience in matrix organizations; proven ability to lead teams and drive quality initiatives.
Excellent communication, presentation, and interpersonal skills.
Strong analytical and problem-solving abilities, with focus on compliance and operational excellence.
Demonstrated ability to mentor, train, and manage cross-functional teams.
Commitment to safety, integrity, and ethical standards in all aspects of work.
Lead a high-impact QA function in a globally recognized organization.
Work on internationally regulated clinical trials and bioequivalence studies.
Opportunity to influence quality systems, audits, and regulatory compliance.
Collaborate with cross-functional teams and global clients, gaining exposure to global best practices.
Syngene International Ltd. provides equal employment opportunities (EEO) to all candidates regardless of age, gender, disability, nationality, religion, sexual orientation, or any legally protected characteristic. Reasonable accommodations are available for qualified individuals with disabilities.
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