✨ About The Role
- The Director of Site Quality will develop and implement quality systems for a 503a registered compounding facility.
- This role involves leading Quality Assurance and Control systems for the production of solid oral dosage, Rx, and OTC products.
- The Director will collaborate with Operations leadership to foster a culture of Quality by Design and Continuous Improvement.
- Responsibilities include approving and releasing all compounded products and managing regulatory inspection activities.
- The position requires oversight of Quality Assurance and Quality Control documentation, ensuring compliance with industry standards.
âš¡ Requirements
- A successful candidate will have a bachelor's degree in Science or Pharmacy, with a preference for advanced degrees.
- The ideal individual will possess over 8 years of experience in Quality Assurance, particularly in environments adhering to current Good Manufacturing Practices.
- Experience with 503A and 503B Outsourcing facilities or pharmaceutical manufacturing is essential for this role.
- The candidate should demonstrate strong leadership skills, having managed teams in a cross-functional and possibly remote setting.
- A deep understanding of cGMP requirements and FDA regulations is crucial for ensuring compliance and quality standards.