Job Description
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
Disclaimer: This job listing is sourced from LinkedIn and is provided for informational purposes. Apply directly through the employer’s application process. Medical Device Navigator is not affiliated with the hiring company.