Senior Quality Engineer, Risk Management
$78,500–$141,000 year
Hybrid · Irvine, California, United States
Job Summary
Senior Quality Engineer, Risk Management supporting QA activities for TPM plants, including approval of manufacturing directions to production, investigations of manufacturing, laboratory, and raw material issues, and CAPA; assess supplier changes, perform annual Product Quality Reviews, and liaise between regulatory areas and TPM sites to ensure compliance with cGMP and QA policies. Role includes reviewing and approving changes, supporting global projects with risk analysis and implementation, participating in Trend Review Board and Global Change Review Board, and generating detailed change management plans. Requires a Bachelor’s degree in Engineering or Science and about six years of pharmaceutical operations experience; familiarity with GMP, supplier change notification, SAP/LRMS systems, and strong communication skills. Hybrid work arrangement in Irvine, CA, with a salary range of $78,500–$141,000 per year.
Required Qualifications
- Bachelor’s degree preferably in Engineering or Science
- Six years of experience within Pharmaceutical operations, preferably Biologic manufacturing process
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Strong analytical skills and attention to detail
- Change plan, SAP and LRMS experience highly preferred
- Strong interpersonal relations / communications skills
- Ability to effectively communicate across all levels of the organization
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