Senior Quality Assurance Manager - BioScience
Murphy Brown(4 months ago)
About this role
Smithfield BioScience is seeking a Quality Assurance leader to oversee cGMP compliance and maintain the integrity of the Quality Management System at an FDA-registered facility producing APIs and medical device components. This full-time role reports to the Head of Quality and focuses on ensuring regulatory compliance with 21 CFR, ICH Q7, ISO 22442 and EU guidelines while supporting inspection readiness and continuous improvement.
Required Skills
- cGMP
- Quality Assurance
- Regulatory Compliance
- Auditing
- CAPA Management
- OOS Investigations
- TrackWise
- QMS
- Team Leadership
- Continuous Improvement
+2 more
Qualifications
- Bachelor's Degree
- Master's Degree
- Certified Quality Manager (CQM)
- Certified Quality Auditor (CQA)
- Six Sigma Black Belt
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