QA Product Line Manager, QA 6

Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.Berkeley, California is a multi-functional Bayer HealthCare site that houses the global headquarters for the Hematology/Cardiology business units, the headquarters of the global biotech product supply organization, and one of three major global R&D sites focusing on protein therapies. In fact, Berkeley is essentially the nerve center of Bayer HealthCare's biotech operations. With a focus on biopharmaceutical discovery, development, manufacturing, and commercialization, we believe our ability to advance improvements and innovations in patient care will be greatly enhanced by our fully integrated capabilities.POSITION DESCRIPTIONThe incumbent serves as the representative for QA and QC on project teams for existing products as well as development products. The incumbent is responsible for outlining the strategy for establishing product specifications/characterizations and process validation requirements. He/she is responsible for working with the validation unit to develop qualification and validation programs for new processes and changes in existing processes.The incumbent serves as an intellectual resource for failure investigations and troubleshooting for all matters related to their licensed product or product/process in development. It is her/his responsibility to resolve all QA issues surrounding their project/product/process responsibility. In addition, the project manager is responsible for notifying management of trends or issues related to product quality.The incumbent is responsible for supplying the proper information to Regulatory Affairs to meet the license requirements in their area of responsibility. This includes annual reports, Part II updates and filings as well as responses to quality-related inquiries by international regulatory authorities.1.Serve on project teams for two to four licensed or development projects2.Develop/update testing strategies for existing products/processes including comparability protocols.3.Provide necessary documentation to Regulatory Affairs for product/process registration4.Work with validation unit to develop and support validation programs5.Work on resolution of NCM reports to expedite product release as well as identify problems/trends and develops action plan to prevent reoccurrence.6.Serve as the interface between Research /Process Sciences and QC to ensure the orderly transfer of new assay methodologies.POSITION REQUIREMENTSBS 10+ YRSMS 6+ YRSPhD 4+ YRS• Influences allocation of resources• Focus is broadly operational• Represents QA to senior management and counterparts in Bayer AG• Helps others manage career paths.