Walker Cole International are searching for a Senior Quality Assurance Manager to join a growing CDMO in in Ohio, USA.
Our client offers end-end services from early drug discovery to commercial manufacturing. As the Senior Quality Manager, you will be responsible for overseeing and managing processes relating to the execution of compliance for the release of bulk drug substance and drug product.
As the Senior Quality Assurance Manager – You will be responsible for:
- Review and approve production batch records
- Review of facility cleaning and GMP records related to facilities and equipment at site
- Generate and review QA Certificates of Analysis
- QA oversight at manufacturing site
- Write and revise SOPs in accordance with cGMPs
- Lead and approve investigations (manufacturing and environmental monitoring)
Required experience for Senior Quality Assurance Manager:
- Bachelor’s degree in relevant scientific field
- Minimum 8+ years of GMP Quality Assurance experience in a CDMO/CMO environment
- A strong understanding in regulations, standards and guidance
- Experience in quality systems, small and large molecules
- Sound knowledge of cGMP auditing practices
Quality | QA | Quality Assurance | GMP | CDMO | CMO | Pharmaceutical | Small molecule | OSD | Large molecule | Biologics | Auditing | Batch Release | SOP | Clinical | Commercial | Manufacturing | Good Manufacturing Practice