Manager, Quality Assurance

Job Description

A high-impact people leadership opportunity at our state-of-the-art Carlow filling site: were hiring a Quality Assurance Manager to lead and develop the QA Batch Release team (11 direct reports) supporting both commercial and clinical supply across biologics and vaccines. As a people leader you will own batch release quality performance set clear goals coach and mentor talent and shape our quality strategy to ensure safe reliable supply for patients. This role sits at a growing strategically important site within the manufacturing networkoffering broad modality exposure accelerated impact and strong visibility across global quality and operations.

Key responsibilities will include:

• Lead develop and mentor the QA Batch Release team (11 reports) setting clear goals and driving performance engagement and growth.
• Own batch release quality outcomes and KPIs including rightfirsttime cycle time deviation CAPA effectiveness and audit readiness.
• Ensure robust compliance with cGMP cGLP and Global Policies; act as the QA decision maker for batch disposition risks and change control impact assessments.
• Partner with IPT leaders Manufacturing QC Technical Ops Supply Chain and Regulatory to enable timely release and continuous improvement across the value stream.
• Lead and support internal and external audits/inspections (HPRA/EMA/FDA) serving as auditee for assigned areas; ensure sustained inspection readiness.
• Provide compliance and technical leadership on investigations and risk assessments elevating root cause quality and preventive action effectiveness.
• Apply Lean/MPS principles and digital tools to simplify quality systems eliminate waste and strengthen data integrity and effectiveness.
• Contribute to site quality strategy talent planning and crosssite/global quality initiatives.

Your profile:

• Bachelors degree (or higher) in a science discipline; postgraduate or QMS qualifications advantageous.
• Significant experience leading QA teams in pharmaceutical sterile manufacturing and/or aseptic filling operations.
• Deep knowledge of cGMP quality systems for aseptic operations and Irish/European/International regulatory standards; experience engaging with HPRA/EMA/FDA preferred.
• Proficiency in Lean/Six Sigma; proven application to quality processes and batch release improvement.
• Progressive people leadership: coaching performance management and building highperforming inclusive teams.
• Strong risk management change management and project leadership across multiple disciplines.
• Analytical systematic problem solving; sound judgment with the ability to make rapid disciplined decisions.
• Excellent communication and stakeholder management able to influence at all levels and with external partners.
• Values that match ours: focus on customers and patients; drive results; build talent; demonstrate ethics and integrity.

What we offer

• Impact: Direct line of sight to patient supply and launch readiness across multiple modalities.
• Growth: Exposure to global quality networks and a clear pathway for advancement.
• Environment: Modern sterile manufacturing and filling technologies; continuous investment in digital QMS and automation.
• Benefits: Include competitive salary range bonus pension healthcare and hybrid work policy as a minimum.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

At our company we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. Were always looking to make a difference for people patients and communities from Ireland to the world.

Our Commitment to Ireland:

Our Company Ireland is one of the Irelands leading healthcare companies having first established here over 50 years ago. We have a dynamic and diverse team of over 3000 employees currently working across seven sites in Ballydine Co Tipperary Brinny Co Cork Dunboyne Co Meath Carlow and Dublin where in addition operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations our Irish sites manufacture many of the companys top products helping save and enhance lives in over 140 countries around the world.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines biologics and small molecule drug its initial launch the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

As a company we are committed to Inventing for Life in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So if you are ready to:

Invent solutions to meet unmet healthcare needs Impact the future by driving one of the worlds leading healthcare companies and inspire your team to reach their full potential and push the boundaries of science and technology please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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