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Director, Clinical Quality Assurance

Meet Life Sciences

Director, Clinical Quality Assurance – Biotech in New York

About Us

Join a cutting-edge biotech business driving the next generation of Cell & Gene Therapy therapies. As the Director of Clinical Quality Assurance, you will play a critical role in establishing the GCP Quality strategy and support multiple clinical studies, directly supporting the development of life-saving therapies.

Why Join Us?

  • Strategic Leadership: Build and lead the Clinical QA function across global clinical programs
  • High-Impact Role: Drive GCP compliance, inspection readiness, and quality strategy across early and late-phase studies
  • Innovation & Growth: Shape quality frameworks within a cutting-edge cell & gene therapy environment

Who We’re Looking For

We’re seeking an experienced Clinical QA leader who thrives in global environments. You bring deep GCP expertise, a strategic mindset, and a proven ability to lead teams while influencing cross-functional stakeholders.

Your Role & Impact

As Director, Clinical Quality Assurance, you will:

  • Define and execute Clinical QA strategy across the full clinical development lifecycle
  • Provide oversight of GCP compliance
  • Lead inspection readiness activities and support Health Authority inspections
  • Drive risk-based quality management and continuous improvement initiatives
  • Act as a subject matter expert for GCP quality assurance across the organization

Key Qualifications

  • Bachelor’s degree in Life Science or similar
  • 10+ years of GCP expertise in Biotech / Pharma
  • Knowledge of global GCP regulations (FDA, EMA, ICH) and GxP frameworks

What We Offer

Join a mission-driven biotech organization at the forefront of innovation in cell and gene therapy. You’ll have the opportunity to shape global quality strategy, lead high-impact initiatives, and work in a collaborative environment focused on delivering meaningful outcomes for patients.

Get in Touch

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

Vacancy posted more than 2 months ago

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