A leading biotechnology organization with a diverse pipeline is seeking an experienced Senior Director, Clinical Quality Assurance to provide strategic leadership across a global clinical development portfolio. This individual will be responsible for shaping and executing the Clinical QA strategy, driving GCP compliance, ensuring inspection readiness, and building scalable quality systems that support innovative therapies from development through commercialization.

This is a highly visible leadership role partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics, and executive leadership to influence quality strategy, risk management, and organizational decision-making.

The ideal candidate is a strategic Clinical Quality leader with a strong track record of building and scaling QA organizations, leading global inspection readiness efforts, and partnering effectively across R&D functions. This individual combines deep technical expertise with executive presence, business acumen, and the ability to drive quality culture across a growing organization.

Key Responsibilities

• Lead the Clinical QA function and develop long-term strategies aligned with business and development objectives.
• Provide oversight of GCP compliance, quality systems, audit programs, and inspection readiness activities across global clinical programs.
• Serve as a trusted advisor on quality and compliance matters to senior cross-functional leadership.
• Drive the evolution of the Clinical Quality Management System (QMS), ensuring alignment with global regulatory requirements and industry best practices.
• Oversee risk-based audit programs for investigator sites, CROs, laboratories, vendors, and external partners.
• Lead regulatory inspection preparedness and support interactions with global health authorities.
• Monitor quality trends, compliance metrics, and emerging risks, providing actionable recommendations to leadership.
• Build, mentor, and develop a high-performing Clinical QA organization.
• Establish departmental priorities, resource plans, budgets, and operational objectives.

Qualifications

• Bachelor’s degree in a scientific, healthcare, nursing, or related discipline with 14+ years of relevant industry experience, or advanced degree with equivalent experience.
• Significant leadership experience within Clinical Quality Assurance, GCP Compliance, or related quality functions in the pharmaceutical, biotechnology, or medical device industries.
• Deep expertise in FDA, EMA, ICH-GCP, and global clinical research regulations.
• Demonstrated success leading regulatory inspections, inspection readiness programs, and global audit strategies.
• Strong knowledge of quality systems, CAPA management, quality risk management, and clinical compliance frameworks.
• Experience supporting Phase I-IV clinical development programs.
• Proven ability to influence executive stakeholders, lead through complexity, and drive strategic organizational initiatives.
• Exceptional communication, leadership, and team development skills.