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.

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.

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

Senior Manager, Supply Chain Quality Assurance

About this role