We have partnered with a global pharmaceutical company to bring on a Sr. QA Manager to provide support for their QA and Compliance department. You will take charge of the management and implementation of their quality systems, ensuring they are compliant with GxP regulations.
RESPONSIBILITIES
- Provide QA support for drug device combination product development throughout its entire life cycle
- Collaborate closely with the R&D team, ensuring any potential risks are appropriately addressed in the design
- Support in review of QA agreements with external customers and suppliers
- Provide and review approval of internal controlled documents
- Conduct compliance audits with 3rd party contractors and consultants
- Support resolution of project team issues
REQUIREMENTS
- Drug combination products, steriles, or biologics experience
- 6+ years of working in an FDA GxP regulated environment
- Strong oral and written communication skills
- BS or equivalent in scientific field or related
