Director, Global Clinical Quality Assurance

EPM Scientific

Nutley (NJ)

In loco

USD 190.000 - 230.000

Tempo pieno

2 giorni fa

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Descrizione del lavoro

EPM Scientific seeks a Director, Clinical Quality Assurance to lead global quality activities for a growing biopharma client in Nutley, NJ. You will shape Clinical Quality strategy, oversee GCP compliance, audits, and inspections, and partner with Clinical Operations, Regulatory Affairs, and external partners.

The role requires 12+ years in Clinical Research or GxP, 5+ years auditing, and deep knowledge of FDA/ICH/EU standards.

Competenze

12+ years in Clinical Research, Clinical Operations, Clinical Quality or GxP environments.
Direct GCP auditing experience with audits of sites, vendors, and systems.
Experience leading regulatory inspections and inspection readiness activities.
Deep knowledge of GCP, ICH, FDA, EU requirements and international standards.
Ability to interact with senior stakeholders and influence decisions.

Mansioni

Lead Clinical Quality Assurance strategy across global programs.
Oversee GCP audits of sites, vendors, and systems; review findings and CAPA.
Drive inspection readiness and support regulatory inspections worldwide.
Provide strategic oversight of quality systems and risk-based programs.
Mentor quality personnel and partner with Clinical Operations and Regulatory Affairs.