Well-known biopharma company in India is looking for a talented individual to join as a Head of Quality Controls (India operations )
• Accountable for all India Quality Control operations
• Lead and drive all operational Quality Control (QC) activities per allocated perimeter, ensuring any products are tested with properly validated methods in a timely, cost-effective, efficient, and fully compliant manner at all times.
• QC method development, transfer, and validation.
• Proactively identify issues and develop solutions in a collaborative multidisciplinary environment
• Enable prompt and effective decision making and troubleshooting of methods and reconciliation of atypical results. Provide direction to QC leaders to ensure project timelines are met.
• Define, implement, monitor testing strategy and plan for the allocated perimeter, defining appropriate metrics, relentlessly seeking and implementing best practices or any improvements • Ensure consistency, standardization, efficiency and cost-effectiveness of approaches • Actively participate to Quality Leadership Team (QLT), lead cross-functional initiatives, proactively support other QLT members where needed
Background & experience required
• M. Sc./Ph.D./Pharm.D. or equivalent in a relevant scientific discipline
• 15-20 years of experience in multinational pharma/biopharma companies, with strong background in Analytical Chemistry, Biochemistry and/or Microbiology and significant exposure to EMA and US FDA requirements
• Experience in managing large teams is required
• Experience with analytical method development, transfer, and validation for drug substance and drug product release and stability testing is required.
• Extensive experience in facing regulatory audits and knowledge of governing regulations and GMPs is required
• Good understanding of Lean principles (Green Belt certification preferred)
*The hired candidate would work from home till it's safe to travel to India where he/she will be based.
(Thank you for your interest in the role and please note that only shortlisted candidates will be contacted)