Quality Assurance Director — Clinical Research

Ready to lead quality at the intersection of clinical trials and regulatory excellence? We're looking for a QA Director to take ownership of GCP compliance and inspection-readiness for a fast-paced clinical pharmacology site — while also playing a key role on a broader, multi-site Corporate QA team. This is a chance to step into a role with real influence: you'll drive audits, own CAPAs from root cause through closure, run the eQMS, and be the trusted go-to for FDA inspections. You'll also mentor and guide QA/QC staff, and step in as backup to the VP of Quality Assurance when needed. What You'll Own Full GCP/FDA compliance for day-to-day trial operations at a busy clinical research siteLeading internal, external, vendor, and sponsor audits — not just supporting themEnd-to-end CAPA program managementDocument control and eQMS oversightTraining programs across QA/QC staffDirect FDA inspection support and readiness What You Bring Bachelor's degree in life sciences, medicine, or equivalent10+ years in pharma, clinical, or device industry, with hands-on audit experience5+ years of FDA/regulatory agency inspection experience strongly preferredSolid grasp of GCP, CFR, and HIPAA requirementsBilingual English/Spanish highly preferredFamiliarity with 21 CFR Part 11 and CSV a plus Why this role: You won't just be maintaining a quality system — you'll be shaping it, with visibility across an entire site's clinical operations and a seat close to senior leadership. If you've led audits (not just checked boxes) and know what it takes to own compliance in a clinical trial environment, we want to hear from you.