We have partnered with a bipharmaceutical company dedicated to developing treatments for rare genetic diseases to find their next Director, CMC Quality Assurance! The ideal candidate will be responsible over all Quality Assurance Manufacturing Operations while implementing their CMC quality approach. They will also ensure that operations are all compliant with GxP regulations as well as my client's standards.
RESPONSIBILITIES:
- Design, develop, and lead QA oversight of the manufacturing and disposal of pre-clinical, clinical, and commercial products
- Directly responsible throughout the design, implementation, and supply of quality product
- Deploy resources to and manage quality agreements
- Manage and develop processes ad talent that provide overall quality oversight to CMOs for small molecules,biologics, and novel therapeutics
- Serve as co-auditor throughout cGMP audits
- Assume leadership roles in CMC teams when needed
- Potentially act as deputy of Quality in governance bodies
REQUIREMENTS:
- 10+ years of GMP Biopharmaceutical manufacturing environment experience in technical operations/and or quality
- Proven leadership experience in completing continuous improvement projects
- Background using risk management tools
- Ability to develop CMC QA vision and mission
- Expert knowledge of cGMPs