Director, Clinical Quality Assurance

The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance.

Requirements

• Bachelor’s degree in a scientific, allied health, or medical field required; Master’s degree preferred
• Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience)
• Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements
• Broad clinical development experience across all phases (Phase I through BLA/NDA)
• Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages
• Proven experience developing and implementing risk-based clinical quality assurance programs
• Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings
• Excellent interpersonal, verbal, and written communication skills
• Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines
• Flexible and creative problem solver with a proactive mindset
• Highly collaborative team player who fosters open communication and cross-functional cooperation
• Willingness to travel up to 20% based on business needs

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship