Manager, Quality Assurance GMP

at  CRINETICS PHARMACEUTICALS

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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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:

This position is primarily responsible for management and oversight of quality processes overseeing manufacturing and supportive operations in compliance with Good Manufacturing Practices (GMP).

EDUCATION AND EXPERIENCE:

Required:

• 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).
• Demonstrate ability to effectively organize, prioritize and work in a fast-paced environment.
• Demonstrate ability to function individually and in a team environment
• Equipment: working knowledge of relevant manufacturing and analytical testing equipment and instrumentation.
• Software Knowledge: MS Office, ERP systems.

Preferred:

• 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).

These may include but are not limited to:

• Serve as the GMP QA partner for the development programs, from early phase through validation
• Perform batch record review, and disposition related activities for Clinical and Commercial Supplies
• Perform review of analytical and microbiological testing data for Drug Substance, Drug Product Intermediates and Drug Product
• Coordinate Quality Events (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
• Review and approves analytical method validations final reports
• 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