Biotech Jobs | Syngene is Hiring Group Lead |
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Ready to step into a leadership role that defines quality and compliance in clinical research? Syngene career opportunities now offer a senior opening for Group Lead – Clinical QA, an ideal role for experienced professionals seeking impactful biotech jobs and high-responsibility life science jobs within a globally trusted organization.
Job Details
- Job Title: Group Lead – Clinical
- Location: Bangalore, KA, IN, 560100
- Division: Essential Functions
About the Company
Syngene International Ltd. is a globally recognized research, development, and manufacturing organization supporting pharmaceutical and biotechnology innovation. Established in 1993, the company delivers integrated scientific solutions across discovery, development, and clinical research. Syngene collaborates with leading global healthcare organizations to accelerate innovation and regulatory excellence. With a strong focus on quality, compliance, and safety, it maintains world-class research standards. The organization fosters a culture of scientific rigor and continuous learning. Syngene career opportunities offer impactful biotech and life science jobs for professionals at all stages.
Key Responsibilities
- Schedule, personally conduct and/or manage resources, for GCP QA audits which will enable the clinical (Bioequivalence studies, Clinical trials (Phase I- III), Clinical data management) operational activities at Translational & Clinical Research (T&CR) operating unit (OU) to ensure quality and compliance to national and international regulatory requirements.
- Develop risk-based audit plan focusing on ethical conduct, safety & medical care of subjects, adherence to protocols, GCP requirements for clinical (Bioequivalence studies, Clinical trials (Phase I- III), Clinical data management) operations and facility audits.
- Provide personal oversight for and/or participate in audits of clinical activities and review clinical, data and documents that will be submitted to sponsors / regulatory authorities.
- Provide oversight of GCP QA auditors to develop specific audit plans, review and assess audit reports, ensuring they meet the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate to ensure compliance with Standard Operating Procedures (SOPs), regulations, and best practices for clinical operations.
- Collaborate with the appropriate clinical operations team in follow-up to external audits to ensure resolution of audit findings in accordance with industry best practices.
- Collaborate with clinical operations in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
- Consult with the concerned Clinical functions regarding perceived GCP-related vendor performance issues and work with them to develop a corrective action plan as needed.
- Perform onsite/remote vendor audits and provide follow-up as indicated.
- Provide follow-up corrective action with proposed and contracted vendor services.
- Lead/assist with investigations of misconduct, serious GCP breach, and other noncompliance issues.
- Identify and appropriately escalate critical quality issues to GCP QA HOD.
- Perform/Oversee root cause analysis (RCA) and corrective action preventative action (CAPA) process.
- Perform/Oversee internal process audits, due diligence, system audits, GCP document audits including trial master file (TMF), and 21 CFR part 11 audits.
- Periodically maintain and report GCP QA team activity metrics, study quality metrics, and trends for assigned programs to GCP QA HOD.
- Assist GCP QA HOD/management in the readiness and hosting of regulatory agency inspections.
Education
M.Sc./ M. Tech in Life Sciences/Biotechnology
Skills and Capabilities:
- Performing and managing Quality Assurance audits in a GCP environment.
- Sound fundamental technical knowledge in BE/BA studies, Clinical research, Drug development, Basic medical sciences, and pharmacology.
- Thorough knowledge in regulatory guidelines (ICH, USFDA, EMA, MHRA) governing clinical development.
- Strategic thinking and goal-oriented with demonstrated good judgment and decision-making experience in a matrix environment.
This leadership role is ideal for professionals seeking senior-level biotech jobs that combine scientific depth with regulatory authority. A Syngene career as Group Lead – Clinical QA offers influence, responsibility, and the opportunity to strengthen global clinical quality systems, making it a rewarding step for experienced candidates in life science jobs.
