Global Clinical QA Executive Director: Strategy

Meet Life Sciences; Massachusetts; On-site; USD 230,000 - 360,000; Full time

Job summary

A pioneering biotech company in Massachusetts is seeking an Executive Director of Clinical Quality Assurance to drive global quality strategy and lead compliance initiatives. Candidates should possess 15+ years of experience in the field along with proven leadership in scaling quality organizations. This role provides an opportunity to shape innovative quality systems in a fast-paced biotech environment. Remuneration is competitive, with an emphasis on transformative contributions to human health.

Qualifications

• 15+ years of Clinical Quality experience within pharma/biotech environments.
• Proven leadership experience building, scaling, and developing high-performing Quality teams.
• Deep knowledge of global regulatory requirements, including FDA and EMA frameworks.

Responsibilities

• Develop and execute the global Clinical QA strategy.
• Establish and maintain GCP quality systems, SOPs, and frameworks.
• Lead risk-based quality management and continuous improvement across programs.
• Oversee vendor qualification, audit programs, and GxP compliance.
• Drive inspection readiness and serve as primary contact for Regulatory Inspections.
• Build, scale, and lead a high-performing Clinical QA organization.

Skills

Clinical Quality experience

Leadership experience

Knowledge of global regulatory requirements

Expertise in biologics development

Education

Bachelor’s degree in a scientific discipline

Job description

A pioneering biotech company in Massachusetts is seeking an Executive Director of Clinical Quality Assurance to drive global quality strategy and lead compliance initiatives. Candidates should possess 15+ years of experience in the field along with proven leadership in scaling quality organizations. This role provides an opportunity to shape innovative quality systems in a fast-paced biotech environment. Remuneration is competitive, with an emphasis on transformative contributions to human health.