Executive Director, Quality

About the role

The Executive Director, Quality leads the Carlow site’s Quality function, overseeing both Quality Assurance and Quality Control. Reporting to the VP of Quality Biologics, this senior leader ensures compliance with regulatory standards and drives the delivery of high‑quality pharmaceutical, vaccine and biologics products.

Key responsibilities

• Lead the site Quality organization, ensuring appropriate structure, resources and development for current and future needs.
• Act as senior quality authority for drug product disposition, batch release oversight and critical compliance decisions.
• Chair the Site Quality Council and maintain an inspection‑ready Quality Management System (QMS).
• Oversee permanent inspection readiness, GMP audit programmes and support regulatory inspections, customer audits and internal audits.
• Manage audit observations, corrective and preventive actions (CAPA), and ensure timely resolution of deviations, investigations and product complaints.
• Sponsor and govern the site Quality Risk Management process.
• Provide quality leadership to Integrated Process Teams and influence site strategy as a member of the Site Leadership Team.

Required profile

• Extensive senior‑level experience in pharmaceutical or biologics quality assurance/control.
• Deep knowledge of US FDA 21 CFR Parts 210 and 211 and EU/EMEA GMP requirements.
• Proven ability to lead large, matrixed quality organizations and drive compliance in a regulated environment.
• Strong track record of managing inspections, audits and risk‑based decision making.

Required skills

• GMP compliance and inspection readiness.
• Regulatory knowledge of FDA 21 CFR 210/211 and EU GMP.
• Quality Management System (QMS) implementation and maintenance.
• Quality Risk Management and CAPA processes.