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. Why Join Us? 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 Who We’re Looking For 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. Your Role & Impact 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 Key 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 Experience in biologics / large molecule development strongly preferred Bachelor’s degree in a scientific discipline or equivalent What We Offer 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. Get in Touch If this opportunity is of interest, please reach out to Guled Samatar at Meet Life Sciences Call: View phone number on click.appcast.io Email: View email address on click.appcast.io #J-18808-Ljbffr