Senior Manager, Supply Chain Quality Assurance

Crinetics Pharmaceuticals • Headquarters, KY

5d • $130,000 - $160,000

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. 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.

Requirements

• 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
• 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.

Nice To Haves

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

Responsibilities

• 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.

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: Mid Level