Aurigene Oncology Hiring: Senior Executive – Clinical Quality Assurance (QA)

Aurigene Oncology, a clinical-stage biopharmaceutical enterprise dedicated to developing cancer therapeutics, is recruiting for the position of Senior Executive – Clinical QA at its Bengaluru facility.

Position Overview

Qualification & Experience

• Educational Background: Master’s degree in Pharmacology, Quality Assurance (QA), Biochemistry, or Biotechnology.
• Relevant Experience: 5 to 8 years of core experience in clinical quality assurance, clinical trial compliance, and regulatory audits.
• Regulatory Expertise: Strong working command of ICH-GCP, New Drugs and Clinical Trials Rules (NDCT 2019), and relevant global clinical research regulations.

Key Responsibilities

• Formulate, maintain, and implement QA processes and standard operating procedures (SOPs) across clinical trials to ensure adherence to statutory norms.
• Scrutinize key clinical trial documentation, including Investigator Brochures (IB), clinical protocols, Informed Consent Forms (ICF), study plans, and procedure manuals.
• Monitor clinical studies to confirm ongoing execution aligns strictly with approved protocols and SOPs.
• Plan and conduct internal and external audits, covering clinical trial sites, CROs, vendors, central laboratories, facilities, and Trial Master Files (TMF).
• Author comprehensive audit reports, flagging findings and categorizing risk based on regulatory impact.
• Drive the evaluation, tracking, and timely closure of Corrective and Preventive Action (CAPA) commitments resulting from audits and inspections.

How to Apply

Interested candidates with relevant expertise should email their updated CV to:

• Email ID: tamil_s@aurigene.com
• Recommended Subject Line: “Application for Senior Executive – Clinical QA – Bangalore”
• Last Date to Apply: 20 October 2026

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