Group Lead - Clinical

The Group Leader -GCP QA (Clinical) at Syngene in Bangalore is responsible for managing the GCP QA auditors team and conducting various audits related to clinical research, process audits, Investigational Site audits, and safety database audits. The role involves assessing systems and practices to improve the GCP Quality System practices in alignment with the national and international GCP Quality System standards. The Group Leader must ensure compliance with quality (GxP) regulations and standards, making the facility audit-ready at all times. Key Responsibilities include: - Scheduling and conducting GCP QA audits to ensure compliance with regulatory requirements - Developing risk-based audit plans focusing on ethical conduct, safety, and adherence to protocols - Providing oversight for audits of clinical activities and reviewing documents for submission to sponsors/regulatory authorities - Collaborating with clinical operations teams for follow-up on external audits and continuous improvement - Leading investigations of misconduct, serious breaches, and noncompliance issues Qualifications and Skills required: - 15 to 20 years of relevant experience in Clinical Research Industry - Education: M.Sc./M. Pharm/M. Tech in Basic Medical Sciences/ Life Sciences/Biotechnology - Experience in managing Quality Assurance audits in GCP environment - Strong knowledge of regulatory guidelines (ICH, USFDA, EMA, MHRA) - Strategic thinking, goal-oriented, and demonstrated good judgment in decision-making The successful candidate will demonstrate alignment with Syngene's core values of Excellence, Integrity, and Professionalism. Syngene is an equal opportunity employer committed to fostering a culture of safety, quality, and compliance in all operations.,