Associate Director of Quality Assurance
Listed on 2026-09-01
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Data Analyst
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.
ResponsibilitiesYou 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 ProfileYou 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.
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