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 serves as a pivotal member of the site quality leadership team responsible for overseeing new product introductions and technology transfer activities.
Candidates will act as a subject matter expert to regulators during inspections while leading robust change management practices for validation lifecycle activities.
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
GxP compliance oversight
Process and equipment validation lifecycle
New product introduction quality oversight
Computer system validation expertise
Regulatory inspection representation
Nice-to-have
Six Sigma or Lean methodology experience
ASQ or ISPE certification
Advanced degree in science or engineering
Strong business requirements analysis skills
Continuous improvement leadership
Key Requirements
Bachelor's degree in scientific or engineering discipline
10+ years pharmaceutical/biotech industry experience
5+ years leadership experience
Experience with Continual Process Verification and Validation Master Plans
Knowledge of FDA, EMA, and ICH regulatory requirements