Manager, Quality Assurance GMP

Crinetics Pharmaceuticals

12d

About The Position

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Manager, Quality Assurance GMP is primarily responsible for management and oversight of quality processes overseeing manufacturing and supportive operations in compliance with Good Manufacturing Practices (GMP).

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)
• Equipment: 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
• Software Knowledge: MS Office, ERP systems

Nice To Haves

• Solid dosage or drug substance experience is preferred, however, experience in other dosage forms with relevant experience is acceptable
• Prior experience with Electronic QMS systems (Veeva preferred)

Responsibilities

• 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
• Other duties as assigned

Benefits

• In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
• We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager