Job Title: Group Lead – Clinical (GCP Quality Assurance)
Location: Bangalore, Karnataka, India
Department: Clinical Operations – Translational & Clinical Research
Employment Type: Full-Time, Permanent
Job Level: Thought Leader
Syngene International Ltd. is a global, innovation-led contract research, development, and manufacturing organization (CRDMO) delivering integrated scientific services across pharmaceuticals, biotechnology, and life sciences industries. Syngene partners with top-tier clients to accelerate drug discovery, clinical development, and regulatory compliance through a combination of scientific expertise, operational excellence, and quality-driven processes.
The Clinical GCP QA function plays a critical role in ensuring regulatory compliance, audit readiness, and high-quality clinical operations, covering bioequivalence (BE) studies, Phase I–III clinical trials, and clinical data management.
The Group Lead – Clinical (GCP QA) will lead a team of QA auditors responsible for study-based, process, vendor, and system audits across clinical operations. The role ensures that Syngene’s Translational & Clinical Research (T&CR) operating units comply with national and international GCP standards, corporate quality policies, and regulatory requirements, while promoting a culture of continuous improvement and operational excellence.
This leadership position requires strategic oversight, expert knowledge in clinical operations, and the ability to drive quality, compliance, and regulatory readiness across multiple projects.
Lead, manage, and schedule GCP QA audits including clinical trials (Phase I–III), bioequivalence studies, clinical data management audits, and site/vendor audits.
Develop risk-based audit plans focused on subject safety, protocol adherence, GCP compliance, and operational quality.
Review clinical trial data, documents, and reports submitted to sponsors and regulatory authorities.
Provide oversight and mentorship to QA auditors, ensuring audit plans, findings, and CAPA recommendations meet quality and compliance standards.
Collaborate with clinical operations teams to resolve audit findings and implement corrective and preventive actions (CAPA).
Conduct root cause analysis (RCA) and manage internal process, system, and trial master file (TMF) audits, including 21 CFR Part 11 compliance.
Oversee vendor audits and ensure corrective actions are implemented effectively.
Lead investigations into serious GCP breaches, noncompliance issues, or misconduct, escalating critical quality concerns as required.
Support readiness for regulatory inspections and ensure T&CR operations are audit/inspection-ready.
Maintain GCP QA metrics, study quality trends, and reporting for management review.
Educational Qualification: M.Sc., M. Pharm, or M. Tech in Basic Medical Sciences, Life Sciences, or Biotechnology.
Experience: Minimum 8–12 years in GCP QA, clinical research, or clinical operations with demonstrated experience in leading audits, compliance, and quality systems.
Strong knowledge of bioequivalence (BE) studies, Phase I–III clinical trials, clinical data management, and regulatory compliance.
In-depth understanding of ICH-GCP, US FDA, EMA, and MHRA guidelines.
Proven experience in strategic thinking, risk-based audit planning, and cross-functional collaboration.
Demonstrated ability to lead, mentor, and manage high-performing QA teams in a matrix organization.
Expertise in GCP Quality Assurance audits, CAPA management, and root cause analysis.
Strong regulatory, clinical operations, and pharmacology knowledge.
Exceptional decision-making, problem-solving, and strategic leadership skills.
Excellent communication, interpersonal, and stakeholder management skills.
Ability to drive a culture of compliance, quality, and continuous improvement.
Lead a high-impact QA function supporting global clinical operations.
Work with world-class clients and cross-functional teams in a fast-paced, quality-driven environment.
Contribute to audit readiness, regulatory compliance, and process improvement at a global scale.
Opportunity to mentor and shape a high-performing QA team while driving strategic initiatives.
Syngene is committed to providing equal employment opportunities to all candidates. Employment decisions are made without discrimination based on age, race, gender, disability, religion, sexual orientation, or any legally protected characteristic. Reasonable accommodations are provided to qualified individuals with disabilities.
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