Manager, Quality Assurance, GMP

Job Description: • Serve as the GMP QA partner for the development programs, from early phase through validation • Review and approve analytical method transfer and validation protocols and final reports for Drug Substance and Drug Product • Review and approve analytical methods and specifications, stability protocols and reports • Perform review and approval of analytical and microbiological testing data for Drug Substance, Drug Product Intermediates and Drug Product • Perform batch record review and disposition related activities for Clinical and Commercial Supplies • Review and approve Master Batch Records, review CMO change controls and provide quality impact assessments relating to proposed changes • Coordinate Quality Events (Laboratory Investigations, Deviations, CAPAs) with CMOs and escalate to QA management as appropriate • Oversee QA aspects of API, Drug Product and Packaging and Labeling Operations for Crinetics products • Represent QA in internal and external team meetings • Support QA team on internal and external GMP audits • Perform and/or review impact assessments and risk assessments • Write and review Standard Operating Procedures • Write internal investigations, as applicable; review external, CMO investigations as assigned • Compile metrics of Batch Disposition, deviations, CAPAs, as applicable • Perform vendor audits as assigned and support vendor lifecycle activities Requirements: • Bachelor’s degree in chemistry, engineering or other scientific discipline • 7 years of relevant experience in a regulated GMP environment with 2 years of supervisory/leadership experience • Demonstrated knowledge of FDA/EMA/ICH standards and regulations • Demonstrated knowledge of Risk Assessment and Root Cause Analysis (5 WHYs, FMEA) • Relevant analytical experience, including understanding and working knowledge of chromatography and chromatographic methods (i.e. HPLC, GC) • Working knowledge of relevant manufacturing and analytical testing equipment and instrumentation • Demonstrate ability to effectively organize, prioritize and work in a fast-paced environment • Demonstrate ability to function individually and in a team environment • MS Office, ERP systems Benefits: • health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance • 20 days of PTO • 10 paid holidays • winter company shutdown • discretionary annual target bonus • stock options • ESPP • 401k match Apply tot his job Apply To this Job