Associate Director of Quality Assurance

Metric Bio; Oregon (WI); On-site; USD 180,000 - 230,000; Full time

Job summary

Metric Bio, a PE-backed CDMO, seeks an Associate Director of Quality Assurance to oversee day-to-day QA operations including investigations, CAPAs, and batch record review for OSD manufacturing and warehouse activities.

You will lead the QA team, ensure cGMP compliance, support regulatory audits, and drive continuous improvement across FDA and EU inspections.

Qualifications

• Strong knowledge of GMP and Quality requirements for preclinical and clinical manufacturing.
• Experience across FDA and EU inspections.
• Cross-functional leadership and clear communication.

Responsibilities

• Lead Quality operations and continuous improvement, overseeing investigations, CAPAs, complaints, change controls, SOPs, batch records and quality documentation.
• Provide Quality oversight across OSD manufacturing, packaging, labeling, raw materials and warehousing, ensuring cGMP compliance and inspection readiness.
• Lead and develop the Quality team and support audits and regulatory inspections.

Skills

GMP/Quality

Cross-functional leadership

Communication

Organizational skills

Analytical skills

Problem-solving

Education

Bachelor's degree in a scientific discipline

Job description

Title: Associate Director of Quality Assurance

Location: Northwest US - Onsite - relocation support is provided!

Context: OSD 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 an Associate Director of Quality Assurance to oversee the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to disposition of raw materials and drug products.

Responsibilities

You will lead Quality operations and continuous improvement, overseeing investigations, CAPAs, complaints, change controls, SOPs, batch records, and quality documentation. You will provide Quality oversight across OSD manufacturing, packaging, labelling, raw materials, and warehousing, ensuring cGMP compliance and inspection readiness. You will also lead and develop the Quality team and support audits and regulatory inspections.

Ideal Profile

You will bring strong knowledge of GMP and Quality requirements for preclinical and clinical manufacturing, with experience across FDA and EU inspections. You will be a strong cross-functional leader with excellent communication, organisational, analytical, and problem-solving skills.

Experience

• Bachelor's degree in a scientific discipline
• 10+ years of GMP/Quality experience in pharma, including OSD manufacturing.
• Experience supporting FDA and EU regulatory inspections.