Description
This position is with one of the most prestigious bio-pharmaceutical companies in the Bay Area. They are looking for an experienced QA manager to come in and oversee their CMOs for solid oral dose commercial products. Being a new position, one can anticipate a lot of room for growth if they can prove themselves leading their direct reports and third-party vendors.Specific Responsibilities:
- Review and approve manufacturing master batch records, executed batch records, in-process/finished product quality control data for timely disposition of drug product intended for human use.
- Prepares lot disposition reports, reviews planned changes, deviations, analytical reports, laboratory investigations, change controls, method and process validation protocols and reports for management review.
- Review and improve existing quality procedure workflows and identify areas of improvement for efficiency. Draft or revise applicable written procedures.
- Interface directly with contract manufacturers, Alliance partners and manage quality related issues by leading investigations and identifying corrective actions.
- Interact with Manufacturing, Quality Control, Materials Management and Regulatory Affairs personnel to ensure that commercial drug products are manufactured and tested in accordance with established procedures
-Some international travel required (~15%).