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:
The Senior Manager, Supply Chain Quality is primarily responsible for management and oversight of quality processes overseeing packaging / labeling, distribution, QP oversight for clinical and commercial supplies, and supportive operations in compliance with Good Manufacturing / Distribution Processes.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Perform batch record review, and disposition related 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 (QP) 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 / 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, CAPAs, as applicable
- Supports GMP QA operations and overall QMS processes, as appropriate.Other duties as assigned.
Education and Experience:
Required:
- Bachelor’s degree in chemistry/Engineering/any scientific discipline
- 12 years of relevant experience in a GMP environment that constitutes Drug Substance, Drug Product, and Packaging and Labeling
- Solid dosage experience is preferred, however, experience in other dosage forms with relevant experience is acceptable
- Prior experience with Electronic QMS systems (Veeva preferred)
- Demonstrated knowledge of FDA/EMA/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. PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
- Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: e-QMS (e. g. Veeva), ERP systems, Interactive Response Technology (IRT) for Clinical Supplies, and Serialization.
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed.
Environmental health and safety requirements also apply.
Travel:
You may be required to travel for up to 10% of your time.
The Anticipated Base Salary Range:
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.
Salary RangeThe salary range for this position is: $130000 - $160000.
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.
