Job Description

Carlow Site Quality Leader

Position Purpose

The Carlow Site Quality Leader is the senior Quality leader for the Carlow site and is accountable for the strategy, governance, and execution of all Quality Unit activities. This role ensures sustained compliance, inspection readiness, and the reliable supply of high-quality products to patients. The role reports directly to the VP, Quality Biologics.

As a member of the Site Leadership Team, the role provides executive leadership and influences site strategy, operational priorities, and risk-based decision-making. The role serves as the site’s senior quality authority and is accountable for ensuring that the site operates in accordance with applicable regulatory requirements, including US FDA 21 CFR Parts 210 and 211, relevant EU/EMEA GMP requirements and annexes as well as other Board of Health requirements.

Carlow is a multi-product commercialization facility supporting pharmaceutical, vaccine and biologics clinical and commercial manufacturing, with significant complexity across inline programs and new product introductions (NPIs). The site includes three drug product manufacturing suites and multiple laboratories supporting analytical testing and stability programs, providing end-to-end support across the clinical and commercial continuum in a highly regulated, matrixed environment.

Key Responsibilities

• Lead the site Quality function, including Quality Assurance and Quality Control, ensuring the organisation is appropriately structured, resourced, and developed to meet current and future business needs.
• Serve as the site’s senior quality authority, with accountability for drug product disposition, batch release oversight, and key compliance decisions.
• Chair the Site Quality Council, ensuring effective management oversight of the Quality Management System (QMS) at Carlow.
• Maintain a robust, current, and inspection-ready Quality Management System.
• Oversee Permanent Inspection Readiness and the GMP audit programme.
• Lead preparation for and support during regulatory inspections, customer audits, and internal audits.
• Ensure effective responses to audit and inspection observations, including timely corrective and preventive actions.
• Sponsor the site Quality Risk Management process and ensure effective governance of quality risk decisions.
• Escalate and manage critical quality issues, deviations, investigations, product quality complaints, and GMP events with urgency and discipline.
• Ensure robust root cause analysis, impact assessment, product disposition decisions, and implementation of effective CAPA.
• Provide quality leadership to Integrated Process Teams and site functions to ensure alignment with cGMP and company requirements.
• Act as a key member of the Site Leadership Team, influencing strategic priorities and risk-based business decisions.
• Ensure consistent release of high-quality products in compliance with regulatory and company requirements.
• Provide oversight of batch disposition and quality decision-making to protect patient safety and product integrity.
• Support seamless execution of clinical and commercial manufacturing activities, including transfers, scale-up, validation, and launch readiness.
• Ensure quality oversight across the product lifecycle, from clinical supply through commercialization.
• Champion a culture of quality, compliance, accountability, and continuous improvement.
• Sponsor and champion continuous improvement in Quality through structured approaches such as Standard Work, Problem Solving, and other operational excellence methodologies.
• Drive simplification, standardization, and right-first-time performance across the Quality organization.
• Foster strong engagement, capability building, and leadership accountability across the site.
• Lead annual budgeting and forecasting for the Quality function and ensure disciplined financial management.
• Build, develop, and retain a high-performing Quality organization with the capability to support both current operations and future growth.
• Provide coaching, succession planning, and performance management for direct reports and broader Quality leadership teams.
• Ensure strong cross-functional collaboration and effective decision-making in a matrix environment.

Qualifications and Experience

• Degree in a relevant scientific, technical, or engineering discipline; advanced qualifications preferred.
• Minimum 15 years of industry experience, including at least 10 years in a Quality role within a GMP-regulated environment.
• Significant leadership experience in Quality within pharmaceutical or biologics manufacturing.
• Proven experience supporting both clinical and commercial manufacturing operations across the product lifecycle.
• Strong background in quality systems, regulatory compliance, risk management, and people leadership.
• Experience in a multi-product commercialization facility, with exposure to biologics manufacturing, analytical operations, and NPI execution strongly preferred.
• Strong ability to influence across functions and deliver through others in a matrix environment.
• Experience managing inspection readiness, regulatory inspections, and audit programmes.

Core Competencies

• Executive leadership and strategic thinking
• Deep technical and regulatory quality expertise
• Sound judgment and risk-based decision-making
• Strong communication and stakeholder management
• People leadership and organisational development
• Continuous improvement mindset
• Integrity, accountability, and patient focus

Success Measures

• Sustained GMP compliance and inspection readiness
• Effective quality governance and timely escalation of issues
• Reliable product disposition and supply continuity
• Strong audit and inspection outcomes
• Development of a capable, engaged, high-performing Quality organization
• Measurable improvement in quality culture and operational performance

Required Skills:

Change Management, Confidentiality, Corrective Action Management, Cross-Cultural Awareness, Key Client Relationships, Motivation Management, Operational Quality, People Leadership, Quality Control Management, Quality Management Systems (QMS), Quality Risk Management, Regulatory Inspections, Results-Oriented, Team Management, Vaccine Manufacturing

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/26/2026

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