Manager Quality CQV
Siegfried · Irvine, CA
QualityFull-time$125k–$135kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Siegfried seeks a Manager of Quality CQV to oversee commissioning, qualification, and validation processes for drug products, medical devices, and manufacturing at their Irvine facility. The role involves managing validation strategy, coordinating cross-functional teams, and ensuring GMP compliance.
What they're looking for
- Bachelor's degree in engineering, science, or related technical discipline
- 6–10 years experience in FDA or GMP-regulated environment
- 6–10 years pharmaceutical industry experience preferred
- 3–5 years supervisory experience managing teams of 5–10 people preferred
- Expertise in CQV activities including sterilization, process validation, and analytical method validation
- Strong GMP compliance knowledge and cleanroom manufacturing familiarity
- Proven ability to analyze validation data, manage direct reports, and lead cross-functional teams
What you'll be doing
- Develop and maintain site validation strategy, master plan, and approach for all CQV processes
- Manage sterilization validation, aseptic process simulation, process validation, cleaning validation, and analytical method validation activities
- Oversee qualification protocols and documentation approval within the Site Validation Master Plan scope
- Coordinate schedules, resources, and deliverables with project management, engineering, and operations teams
- Manage QA sterilization validation group and external validation consultants; represent CQV program in regulatory inspections and audits
Privacy & handoff
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