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 site
• Leading internal, external, vendor, and sponsor audits — not just supporting them
• End-to-end CAPA program management
• Document control and eQMS oversight
• Training programs across QA/QC staff
• Direct FDA inspection support and readiness

What you bring:

• Bachelor's degree in life sciences, medicine, or equivalent
• 10+ years in pharma, clinical, or device industry, with hands-on audit experience
• 5+ years of FDA/regulatory agency inspection experience strongly preferred
• Solid grasp of GCP, CFR, and HIPAA requirements
• Bilingual English/Spanish highly preferred
• Familiarity 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.