Executive Director, Clinical Quality Assurance
Meet Life Sciences
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Job summary
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 with biologics/large molecule development preferred.
Responsibilities
- 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.
Skills
Education
Job description
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: 646-582-3675
- Email: guled.samatar@meetlifesciences.com
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