Junto HLS is working directly with Leadership at a Top 20 pharma to recruit a Senior Manager, Quality Assurance.
- Managing all Oral Solid Dosage products from API through final packaging including the integration of new products.
- Develop and implement strategic risk based lean approaches to the batch review and disposition process.
- Serve as QA representative to cross functional project teams such as tech transfer, computer systems, process improvement, etc.
- Identify and propose Quality process and system improvements by leading improvement projects.
- Initiate, monitor and complete change controls related to Quality topics.
- Monitor suppliers and lead off-site visits and teleconferences for discussion and review of supplier performance to established schedules and cGMP compliance.
- Initiate, revise and review controlled cGMP documents including SOPs, Material Specifications, and investigation protocols and reports as applicable.
- Partner with CMO’s to develop and monitor applicable quality metrics.
- Identifies and facilitates continuous improvement efforts to improve CMO batch release metrics as needed.
- Being accountable for the commercial API lot review and release process.
- Participating in issue detection and resolution with API manufacturers.
- Help to monitor and improve Quality Systems through data collection, calculation, and reporting on departmental performance metrics.
- Participate on investigation teams and ensure proper close out and follow-up.
- Review and approve process, assay, and other validation protocols and reports as applicable.
- Prepare and review applicable sections of regulatory submissions and applicable sections of the Annual Product Review.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.