This role ensures the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within manufacturing and analytical environments
Job Summary
This role ensures the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within manufacturing and analytical environments.
The position involves pivotal oversight of new product introductions and technology transfer activities to ensure seamless integration across supply nodes.
Candidates will serve as a subject matter expert to regulators during inspections while leading a team responsible for robust change management practices.
Matching Summary
This role ensures the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within manufacturing and analytical environments.
Skills & Requirements
Must-have
Bachelor's degree in science or engineering
10+ years pharmaceutical industry experience
5+ years leadership experience
Process and equipment lifecycle management
GxP compliance oversight
Nice-to-have
Advanced degree in relevant discipline
Six Sigma or Lean methodology experience
ASQ or ISPE certification
Strong regulatory knowledge FDA EMA ICH
Continuous improvement mindset
Key Requirements
Bachelor's degree in Chemistry, Biology, Pharmacy, or Engineering