Job Description
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: [email protected]