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
• 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