Manager, Quality Control

The Quality Control Manager is responsible for ensuring that all activities conducted at the analytical Contract Manufacturing Organizations (CMO) laboratories are conducted in compliance with Current Good Manufacturing Practices (cGMP).  A large portion of the position’s responsibilities will be the critical review of analytical test packages for release testing, in-process testing, and stability testing of clinical/commercial supplies (both DS and DP).  This will involve verification that test methods/procedures are followed as written, and documentation is both complete and accurate. 

• →Review of analytical data for release, stability, and in-process testing at the contract manufacturing organizations in a timely manner.
• →Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results.
• →Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages.
• →Submitting test packages to QA for their review and loading all data into the electronic storage program.
• →Review of analytical data related to reference standard qualification, method validation and method transfer activities.
• →Travel, when necessary, to analytical testing sites or other sites

This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

• M.S./B.S. in life sciences, ideally Chemistry, Analytical Chemistry preferred.
• 5+ years’ experience in Quality Control in a pharmaceutical setting with solid knowledge of Good Manufacturing Practices (cGMP)
• 2+ years management experience
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.