Director of Quality Assurance
Role summary
Metric Bio is seeking a Director of Quality Assurance for a PE-backed CDMO based in Oregon, US. This onsite role requires a strong leader with 10+ years of GMP Quality experience, including 5+ years in QA leadership. The Director will oversee QA operations, drive continuous improvement, and ensure compliance with cGMP, FDA, and EU regulations. Responsibilities include managing quality systems, investigations, CAPAs, audits, change control, and reporting quality metrics. The ideal candidate possesses expertise in GMP/aseptic processing, strong analytical and communication skills, and a Bachelor's degree in a scientific discipline.
Title:
Director of Quality Assurance
Location:
Oregon, US - Onsite - relocation support is provided!
Context:
CDMO
About the job
\*\*\*Candidates need to be based within the US for consideration\*\*\*
Metric Bio are proud to be partnered with a PE-backed CDMO on the hunt for a Director of Quality Assurance to oversee QA operations, guide continuous improvement initiatives, and ensure the integrity of quality systems and documentation.
Responsibilities
- Lead and develop QA team, driving quality culture and continuous improvement
- Maintain quality systems, documentation, and validation activities
- Manage investigations, CAPAs, audits, change control, and document control
- Ensure compliance with cGMP, FDA, and EU requirements
- Support internal/external audits and inspections
- Report quality metrics and collaborate cross-functionally
- Manage QA resources and support wider company initiatives
Ideal Profile
- Strong GMP/aseptic expertise with experience in FDA/EU inspections
- Influential communicator with strong analytical and problem-solving skills
- Proven leader able to manage multiple priorities and build strong relationships
- Proficient with standard software tools
Education & Experience
- Bachelor’s degree in a scientific discipline (advanced degree preferred)
- 10+ years of GMP Quality experience; 5+ years in QA leadership
If you meet the requirements - let's have a conversation
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