Job Title: Group Lead – Clinical GCP Quality Assurance (QA)
Location: Bangalore, Karnataka, India (PIN 560100)
Division: Essential Functions
Experience Required: 7–12 years in GCP QA, Clinical Research, or Clinical Operations
Company Overview:
Syngene International Ltd. is a global, innovation-driven contract research organization (CRO) providing integrated services in discovery, development, and manufacturing. With a strong presence in R&D, clinical trials, and translational services, Syngene partners with leading pharmaceutical, biotechnology, and healthcare companies worldwide. Our teams are committed to delivering scientific excellence while maintaining the highest standards of quality, compliance, and regulatory integrity.
Role Overview:
The Group Lead – Clinical GCP QA is responsible for leading the GCP QA auditing team and overseeing all quality assurance activities across clinical operations, including bioequivalence studies, clinical trials (Phase I–III), and clinical data management. This role ensures that Syngene’s Translational & Clinical Research (T&CR) services meet national and international GCP standards, remain audit-ready, and uphold the highest quality compliance.
Key Responsibilities:
GCP QA Leadership & Auditing:
Lead, mentor, and manage the GCP QA auditors team to conduct study-based, process, site, and system audits.
Develop and execute risk-based audit plans focused on patient safety, ethical conduct, protocol adherence, and regulatory compliance.
Review clinical data, trial documents, and audit reports submitted to sponsors and regulatory authorities.
Oversee Corrective and Preventive Action (CAPA) plans to ensure regulatory compliance and continuous improvement.
Perform or supervise internal process audits, due diligence audits, TMF audits, and 21 CFR Part 11 audits.
Conduct root cause analysis (RCA) for quality deviations and implement effective CAPA strategies.
Collaboration & Compliance:
Work closely with clinical operations teams to resolve audit findings and implement lessons learned.
Collaborate with vendors and partners to address GCP compliance issues and develop corrective action plans.
Support regulatory inspection readiness and participate in hosting inspections.
Ensure all clinical QA activities adhere to company SOPs, ICH, USFDA, EMA, MHRA, and other relevant guidelines.
Promote a culture of quality, EHS compliance, and operational discipline across the T&CR operating unit.
Strategic & Analytical Contribution:
Maintain and report GCP QA team metrics, study quality metrics, and trends to management.
Provide expert guidance on GCP-related vendor performance, compliance issues, and process improvements.
Lead investigations of serious GCP breaches, noncompliance, and misconduct cases.
Mandatory Safety & Compliance Expectations:
Adhere to all EHS, data integrity, and quality compliance requirements.
Ensure team compliance with mandatory safety and quality trainings.
Contribute to the development of safe operational procedures and promote a safety-first culture.
Education & Qualifications:
M.Sc., M.Pharm, or M.Tech in Basic Medical Sciences, Life Sciences, Biotechnology, or related fields.
7–12 years of experience in GCP QA, clinical trials, or clinical operations with audit management experience.
Strong technical knowledge in bioequivalence studies, clinical research, drug development, and pharmacology.
Thorough understanding of regulatory guidelines governing clinical development (ICH, USFDA, EMA, MHRA).
Skills & Competencies:
Expertise in conducting and managing GCP QA audits and CAPA processes.
Strategic thinking with strong judgment, decision-making, and leadership skills in a matrix environment.
Excellent communication, interpersonal, and team collaboration skills.
Ability to plan, prioritize, and manage multiple clinical QA initiatives effectively.
Why Join Syngene:
Lead clinical QA excellence in a globally recognized, innovation-driven CRO.
Work on cutting-edge clinical trials and translational research programs.
Collaborate with multidisciplinary teams in a high-growth, professional, and compliance-focused environment.
Equal Opportunity Employer:
Syngene International Ltd. provides equal employment opportunities to all qualified individuals without regard to age, color, national origin, citizenship, disability, race, religion, gender, sexual orientation, gender identity, genetic information, marital status, veteran status, or any other legally protected characteristic. Reasonable accommodations are provided for qualified individuals with disabilities.
Apply Now to advance your career as Group Lead – Clinical GCP QA and lead quality assurance initiatives in clinical research at Syngene, Bangalore.
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