• 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.