Providing strategic and operational quality leadership across Chemistry, Manufacturing, and Controls (CMC) activities
Ensure compliance with global Good Manufacturing Practice (GMP) requirements
Partner cross-functionally with Manufacturing, Quality Control, Operations, Regulatory Affairs, and external manufacturing partners (CMOs/CDMOs)
Drive quality excellence, inspection readiness, and robust control strategies throughout the product lifecycle
Develop and execute quality strategies that support commercial and commercializing programs
Oversee GMP activities including batch disposition, deviation management, change control, and validation
Establish and strengthen quality systems, driving continuous improvement initiatives
Build strong relationships across internal teams and external partners

Bachelor’s degree in a relevant scientific discipline such as: Pharmaceutical Sciences, Life Sciences (Chemistry, Biochemistry, Microbiology, etc.), Pharmacy, Engineering, advanced degree preferred.
8+ years experience in Quality within the pharmaceutical or biotechnology industry, Manufacturing, Tech Services, and/or Regulatory Affairs
Strong understanding in GMP, Quality Management Systems, Risk Management, Regulatory frameworks (FDA, EMA, ICH guidelines, etc.)
Excellent leadership and communication skills with the ability to influence and collaborate across departments
Demonstrated success in driving continuous improvement initiatives and achieving measurable results
Experience in risk management, root cause analysis, and CAPA (Corrective and Preventive Action) processes

Senior Manager, Commercial Product Quality

Key skills