Title: Associate Director, Clinical Quality Assurance
Location: Boston, MA
A clinical-stage biopharmaceutical company is seeking an Associate Director of Clinical Quality Assurance to join the team as they continue to develop treatments for autoimmune diseases. The position will be primarily responsible for QA/Compliance for product disposition, as well as provide guidance and oversight of clinical development, clinical operations, and CMC manufacturing activities.
Responsibilities
- Continuous improvement of company QMS
- Review/approval of lot COAs
- Provide QA support of quality events, change controls, investigations, risk assessments, CAPAs, effectiveness checks
- Quality oversight of CMOs - batch disposition, review, deviations
- Perform vendor GxP audits as needed, participate in product complaint investigations, and recalls as necessary
Qualifications
- BA/BS and min. 8-10 years in a Quality function within a GxP environment
- Strong knowledge of Clinical Quality, Quality systems, and GxP regulations
- Highly motivated, flexible, great organization skills, collaborative
- Able to meet travel requirements (10-15% domestic)
If this sounds interesting, please do not hesitate to apply!
