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 and develop the site Quality organization to meet current and future business needs.
• Act as the 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.
• Oversee permanent inspection readiness, GMP audit programmes and preparation for regulatory inspections and customer audits.
• Drive effective response to audit findings, root‑cause analysis, corrective and preventive actions (CAPA).
• Sponsor and govern the site Quality Risk Management process.
• Escalate and manage critical quality issues, deviations, investigations, product complaints and GMP events.
• Provide quality leadership to integrated process teams and influence site strategy as a member of the Site Leadership Team.

Required profile

• Senior leader with extensive experience in pharmaceutical/biologics manufacturing quality.
• Demonstrated accountability for regulatory compliance with US FDA 21 CFR Parts 210/211 and EU/EMEA GMP requirements.
• Proven ability to lead a Quality Management System and drive inspection readiness.
• Strong decision‑making skills for batch disposition, risk management and CAPA implementation.

Required skills

• GMP compliance and regulatory knowledge (FDA 21 CFR, EU/EMEA GMP).
• Quality Management System (QMS) implementation and oversight.
• Quality Risk Management (QRM) and CAPA processes.
• Audit and inspection preparation and response.
• Batch release and product disposition authority.