Crinetics Pharmaceuticals

Senior Manager, Supply Chain Quality Assurance

Crinetics Pharmaceuticals

full-time

Posted on:

Location Type: Remote

Location: California • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $130,000 - $160,000 per year

Job Level

Senior

About the role

  • 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.

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
  • 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.
Benefits
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
batch record reviewdisposition activitiesQuality Events managementGMP auditsStandard Operating Procedures writingimpact assessmentRoot Cause AnalysisRisk Assessmentanalytical testingquality control oversight
Soft Skills
organizational skillsteamworkcommunicationproblem-solvingability to work in fast-paced environment