Executive Director, Clinical Quality Assurance

Executive Director, Clinical Quality Assurance – International Biotech in Massachusetts About Us

Join a pioneering, global biotech dedicated to transforming human health. Leveraging a cutting‑edge platform, we are advancing innovative therapies across multiple therapeutic areas.

As Executive Director, Clinical Quality Assurance, you will play a critical leadership role in driving quality, compliance, and operational excellence across a growing clinical pipeline.

• Executive Leadership: Shape and lead global Clinical QA strategy across a cutting‑edge clinical portfolio
• High‑Impact Role: Drive GCP, GVP, and GLP compliance while ensuring inspection readiness and quality excellence
• Innovation & Growth: Partner with senior leadership to build scalable quality systems in a rapidly evolving biotech environment

We’re seeking a strategic and hands‑on Clinical QA executive who thrives in fast‑paced environments. You bring global GCP expertise, strong leadership experience, and a proven ability to build and scale quality organizations aligned with clinical development goals.

As Executive Director, Clinical Quality Assurance, you will:

• 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

• 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
• Experience in biologics / large molecule development strongly preferred
• Bachelor’s degree in a scientific discipline or equivalent

Join a mission‑driven biotech redefining what’s possible in human health. You’ll have the opportunity to shape global quality strategy, lead high‑impact initiatives, and drive meaningful outcomes for patients, all within a collaborative, forward‑thinking environment.

If this opportunity is of interest, please reach out to Guled Samatar at Meet Life Sciences

• Call:
• Email: guled