Manager, Quality Assurance

Job Description

A high-impact people leadership opportunity at our state-of-the-art Carlow filling site: we’re 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 network—offering 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 right‑first‑time, 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 cross‑site/global quality initiatives.

Your profile:

• Bachelor’s 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 high‑performing, 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 world’s 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. We’re 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 Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 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 company’s 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 product. Since 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 world’s 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 world’s 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:

Decision Making, Detail-Oriented, Driving Continuous Improvement, GMP Compliance, Key Performance Indicators (KPI), Management Process, People Leadership, Quality Assurance (QA), Quality Assurance Processes, Quality Auditing, Quality Control Systems, Quality Documentation, Quality Management Standards, Quality Management Systems (QMS), Regulatory Requirements, Risk Management, Root Cause Analysis (RCA), Strategy Development, Supplier Quality Management, Team Management

Preferred Skills:

Coaching, Leadership, People Management

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/24/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.