Senior Manager, Quality Assurance
Our client, a growing pharmaceutical and biologics manufacturer, is looking to hire an experienced Senior Manager of Quality Assurance. This person would oversee QA operations supporting analytical and microbiology labs, ensuring cGMP compliance and operational efficiency across quality systems and laboratory testing processes. This opportunity is offered on a full-time and permanent basis, and is based onsite in Costa Mesa, CA.
Base salary:$120-140,000/year.
Key Responsibilities:
- Lead and develop QA staff supporting QC and microbiology labs
- Oversee batch record review, product release, change control, deviations, CAPAs, and annual product reviews
- Drive compliance across QC operations, ensuring data integrity and adherence to regulatory standards
- Partner cross-functionally with QC and manufacturing teams to meet timelines and customer needs
- Support and present during external audits and regulatory inspections
- Champion continuous improvement and implement LEAN initiatives in quality operations
What We're Looking For:
- BS in a scientific or engineering discipline
- 10+ years in QA within pharma, biotech, or biologics manufacturing
- 5+ years overseeing QA functions in a QC lab environment
- Strong leadership background (8+ years in supervisory or management roles)
- Deep knowledge of cGMP regulations (US, EU, Canada, Japan)
- Hands-on experience with quality systems including deviations, CAPAs, change control, and product release
- Comfortable presenting to regulatory bodies and leading technical investigations
- Certifications in ASQ, Green Belt, or Lean Six Sigma a plus
If interested, please apply with an up to date copy of your resume.
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