Job Summary
A company is looking for a Director, Head of the Product Quality Controls & Performance Systems (CPS) in the United States.
Key Responsibilities:
- Lead a team responsible for strategic stability program design and execution
- Oversee the Annual Product Review process for assessing manufacturing data
- Manage the product specification document lifecycle process
Qualifications:
- 12+ years of experience in Biotechnology, Pharmaceutical, or Medical Device industry
- Extensive knowledge of GMP and GDP global regulations
- Experience in stability study design and statistical data analysis
- Prior experience in Quality, Compliance, Manufacturing, or Regulatory roles
- BA/BS/Ph.D in life sciences or related field
