Senior Quality Engineer, Risk Management
$78,500–$141,000 year
Hybrid · Tempe, Arizona, United States
Job Summary
Senior Quality Engineer, Risk Management responsible for QA activities related to TPM plants and PQA functions, including approval of manufacturing directions, investigations of manufacturing, laboratory, and raw material events, product impact analyses and CAPA, review of supplier change notifications, process tracking and trending, and annual Product Quality Reviews. Acts as liaison between AbbVie regulatory areas and TPM sites for regulatory submission. Ensures TPM production complies with cGMP, local procedures, and AbbVie Quality standards; participates in Global Change Review Board and Trend Review Board; supports global projects with risk analysis and implementation. Requires a Bachelor’s degree in Engineering or Science and six years of pharmaceutical operations experience; knowledge of GMP/cGMP, SAP and LRMS preferred; strong communication and analytical skills.
Required Qualifications
- Bachelor’s degree preferably in Engineering or Science
- Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Strong analytical skills and attention to detail
- Change plan, Exception Reports, SAP and LRMS experience is highly preferred
- Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
- Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
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