Associate Director Clinical Quality Assurance and GxP Compliance
$199,200–$246,100 year
HybridNovato, California, United States
Job Summary
Lead strategic oversight for quality assurance strategies, policies, and programs ensuring alignment with U.S. FDA, EMA, and ICH-GCP regulations. Direct the evaluation of non-compliances across clinical programs and drive sustainable, cross-functional solutions. Provide high-level governance for the GCP Audit Program, including planning, execution, and risk mitigation for complex audits like For-Cause and systemic failures. Serve as the senior SME during regulatory inspections, leading issue presentation and cross-functional coordination. Establish the enterprise Clinical Program Inspection Readiness strategy, overseeing mock inspections, vendor risk identification, and TMF management improvements. Mentor QA personnel and contract service providers while championing a culture of compliance excellence. This hybrid role requires 2-3 days onsite weekly with approximately 30% travel. The Associate Director reports to senior leadership and partners with cross-functional stakeholders to drive operational efficiency and quality maturity.
Required Qualifications
- Bachelor's Degree in a scientific or related technical discipline
- At least 7+ years' experience in health-care field or setting, or in Biotech/Pharmaceutical industry
- 3-6 years Quality Assurance or Compliance experience
- Able to establish and execute Quality goals for a forward-looking 3-5 year period that aligns to company-wide objectives
- Broad and direct experience with leading or organizing regulatory authority inspections
- Travel: approximate 30% (if needed)
Desired Qualifications
- At least 7+ years' experience in health-care field or setting, or in Biotech/Pharmaceutical industry with 3-6 years Quality Assurance or Compliance experience preferred
- Strategic thinker, open-minded and flexible to adopting new ideas
- Excellent communications skills, both written and verbal
- Flexible in the face of shifting needs and/or priorities
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