Director, Clinical Quality

186696
  • 200000 USD - 235000 USD
  • RTP, United States
  • Permanent

Director, Clinical Quality Assurance – Biotech in North Carolina

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

  • Call: 646-582-3675
  • Email: guled.samatar@meetlifesciences.com
Guled Samatar Division Manager

Apply for this role

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