Lead Clinical Quality

Responsibilities

• Provide strategic quality oversight for biosimilar clinical trials to ensure compliance with GCP and global regulatory standards
• Develop and lead a global, risk-based audit strategy for investigator sites, CROs, and bioanalytical laboratories
• Plan, conduct, and manage the lifecycle of audits, including the review and approval of CAPA plans
• Perform independent quality reviews of clinical protocols, Study Reports (CSRs), and essential regulatory documentation
• Lead inspection-readiness activities and support Health Authority inspections (USFDA, EMA, etc.)
• Build and continuously improve the Clinical Development Quality Management System (QMS)
• Develop clinical quality metrics and dashboards to provide visibility on compliance status and risks
• Oversee clinical vendor management and provide QA support for Data Management Systems (DMS)

Requirements

• Post-Graduation in Sciences, Pharmaceuticals, or Engineering
• 10 to 14 years of experience in pharmaceutical or biopharmaceutical industries (QA, QC, R&D, or Manufacturing)
• Strong understanding of Quality Systems and deep knowledge of cGMP
• Proficient auditing skills with experience in clinical service provider oversight
• Comprehensive knowledge of global regulatory guidelines (USFDA, EMA, ICH, etc.)
• Strong communication, influencing, and risk-based decision-making skills

Benefits

• Personalized learning programs to catalyze career growth and professional development
• Benefits that are on par with the best industry standards

About the Company

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company dedicated to accelerating access to affordable and innovative medicines. With a presence in 66 countries, we operate with a purpose-driven mission to reach over 1.5 billion patients by 2030 through deep science, innovation, and robust corporate governance.