Executive Director, Clinical Quality Assurance

Meet Life Sciences

Massachusetts

In loco

USD 230.000 - 360.000

Tempo pieno

14 giorni+

Aumenta le possibilità di ricevere una risposta da questo datore di lavoro

Il tuo curriculum e una lettera di presentazione personalizzati, che corrispondono esattamente a ciò che sta cercando.

Supera i filtri ATS

Descrizione del lavoro

A pioneering biotech company in Massachusetts is seeking an Executive Director of Clinical Quality Assurance to drive global quality strategy and lead compliance initiatives. Candidates should possess 15+ years of experience in the field along with proven leadership in scaling quality organizations. This role provides an opportunity to shape innovative quality systems in a fast-paced biotech environment. Remuneration is competitive, with an emphasis on transformative contributions to human health.

Competenze

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.

Mansioni

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.

Conoscenze

Clinical Quality experience

Leadership experience

Knowledge of global regulatory requirements

Expertise in biologics development

Formazione

Bachelor’s degree in a scientific discipline

Descrizione del lavoro

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