Senior Director, Clinical Quality Assurance

Senior Director, Clinical Quality Assurance
Location: U.S. (Remote, East-coast based preferred)

We're partnering with a late‑stage clinical biopharmaceutical company to hire a Senior Director, Clinical Quality Assurance to lead the global GCP quality program and provide quality oversight for late‑phase clinical development.

This is a highly visible leadership role responsible for ensuring global clinical trials - including Phase III studies - are inspection‑ready and compliant with ICH‑GCP, regulatory requirements, and internal quality standards.

What you'll be responsible for:

• Lead the global Clinical Quality Assurance (CQA) strategy and governance model
• Own and maintain a robust GCP Quality Management System
• Provide quality oversight for global Phase I-III clinical trials, with emphasis on Phase III
• Identify and mitigate GCP risks through risk‑based QA assessments
• Oversee vendor qualification, CRO oversight, and site quality activities
• Serve as the GCP SME and key partner to Clinical Operations, Regulatory, PV, Biostatistics, Data Management, and external partners
• Lead and support regulatory inspections (FDA, EMA, MHRA, PMDA, etc.) from a GCP perspective
• Drive audit strategy including CRO, investigator site, vendor, TMF, and internal audits
• Ensure effective CAPA development, implementation, and follow‑up
• Develop, review, and improve SOPs, quality metrics, and dashboards
• Promote a strong quality culture focused on transparency, inspection readiness, and continuous improvement
• Manage and develop a small clinical quality team, including internal staff and contractors

Background requirements:

• Bachelor's degree in a scientific or healthcare discipline (advanced degree preferred)
• 15+ years of experience in clinical quality, clinical development, or clinical operations
• 10+ years of hands‑on GCP / ICH clinical quality assurance experience
• Extensive experience supporting global Phase III clinical trials
• Strong auditing background; certifications a plus
• Deep knowledge of US and international GCP and regulatory expectations
• Direct experience leading or supporting global regulatory inspections
• Strong CRO oversight and vendor management experience
• Proven senior‑level communicator with excellent technical writing skills
• Comfortable operating in a fast‑paced, growing biotech environment
• Familiarity with eTMF, CTMS, and QMS platforms
• Willingness to travel up to ~25%

Why this role:

• Senior leadership role with direct impact on late‑stage development programs
• Opportunity to shape and mature the clinical quality function
• High exposure to executive leadership and global regulatory interactions
• Rare blend of strategic ownership and hands‑on clinical quality leadership