Position Details
About this role
Senior Quality Engineer, Risk Management provides QA support for Third Party Manufacturing plants, ensuring GMP compliance, overseeing investigations and CAPA, and collaborating with Regulatory and TPM to support global quality initiatives.
Key Responsibilities
- Maintains liaison with Quality, Regulatory, Technical, and TPM sites
- Ensures TPM production adheres to cGMP and AbbVie QA requirements
- Review and approve manufacturing directions and investigations
- Support global projects with planning, risk analysis, and implementation
- Participate in Trend Review Board and GCRB for supplier changes and regulatory submissions
Technical Overview
Focus on cGMP compliance, QA investigations, CAPA, trend analysis, and regulatory submissions; utilizes SAP and LRMS to manage quality processes and changes across TPM sites.
Ideal Candidate
The ideal candidate is an experienced senior quality engineer with 6+ years in pharmaceutical operations, well-versed in GMP/cGMP, CAPA, QA investigations, and SAP/LRMS, who can lead quality oversight at a GMP site and interact with regulatory and manufacturing teams.
Must-Have Skills
Nice-to-Have Skills
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Bachelor's degree not held, Less than 6 years pharmaceutical operations experience, Inability to work onsite in Irvine, CA
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