Manager, Quality Assurance GMP
- 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
- 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.
- 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).
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $102,000-$136,000
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.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Vaccination requirement:
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.