Crinetics Pharmaceuticals, Inc. is seeking a Senior Manager, Supply Chain Quality Assurance to manage and oversee quality processes for packaging, labeling, and distribution of clinical and commercial supplies. You will be responsible for ensuring compliance with Good Manufacturing and Distribution Practices.
What You'll Do
- Perform batch record review and disposition activities for Clinical and Commercial Supplies.
- Coordinate and manage Quality Events (Deviations, CAPAs) with CMOs and escalate them to QA management.
- Oversee QA Packaging / Labeling Operations and distribution for Crinetics products.
- Review and approve labeling artwork for clinical and commercial product.
- Partner with Clinical Trial Supply organization to develop schedule and strategy for packaging and release activities including Qualified Person oversight.
- Represent QA in internal and external team meetings.
- Support QA team on internal and external GMP/GDP audits.
- Support QA management on compiling Quality associated metrics.
- Lead or support QA management on field-related activity such as complaints, Field Alerts, Recall / Withdrawal, and notification to regulatory agencies.
- Perform impact assessment and disposition for supplies that are subjected to temperature excursion.
- Write and review Standard Operating Procedures.
- Write and approve internal investigations, as applicable.
- Compile metrics of Batch Disposition, deviations, and CAPAs.
- Support GMP QA operations and overall QMS processes.
What We're Looking For
- Bachelor’s degree in chemistry, Engineering, or a scientific discipline.
- At least 12 years of relevant experience in a GMP environment covering Drug Substance, Drug Product, and Packaging and Labeling.
- Prior experience with Electronic QMS systems (Veeva preferred).
- Demonstrated knowledge of FDA, EMA, and ICH standards and regulations.
- Demonstrated knowledge of Risk Assessment and Root Cause Analysis (5 WHYs, FMEA).
- Demonstrated ability to effectively organize and work in a fast-paced environment.
- Demonstrated ability to function individually and in a team environment.
- Working knowledge of relevant manufacturing equipment and operations and analytical testing and quality control oversight.
- Proficiency with Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of e-QMS (e.g., Veeva), ERP systems, Interactive Response Technology for Clinical Supplies, and Serialization.
Nice to Have
- Solid dosage experience is preferred, however, experience in other dosage forms with relevant experience is acceptable.
Technical Stack
- Windows, MS Office (Outlook, Word, Excel, PowerPoint)
- e-QMS (e.g., Veeva)
- ERP systems
- Interactive Response Technology (IRT) for Clinical Supplies
- Serialization
Benefits & Compensation
- Compensation: $130,000 - $160,000
- Discretionary annual target bonus
- Stock options
- ESPP
- 401k match
- 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
- Winter company shutdown
Work Mode
This is an onsite position located in San Diego, California.
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, 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.
