Director of Quality Assurance

About the job

Location: Oregon, US - Onsite - relocation support is provided!

Context: CDMO

***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

#J-18808-Ljbffr