Mgr, Quality Assurance

Job Description

We’re hiring for a QA Manager to join our Quality Assurance Integrated Process Team. You will report to the Associate Director, Quality Assurance Integrated Process Team, collaborate closely with our existing team of QA  Managers and Senior Specialist, and play a key role in safeguarding product quality and patient safety. This opportunity is ideal for an experienced Quality professional who thrives in a fast-paced, collaborative manufacturing environment and is committed to delivering safe, compliant products.

Bring energy, knowledge, innovation to carry out the following:

• You will provide expert Quality input and subject matter insight across three manufacturing suites, supporting timely and effective issue resolution.

• Serve as the Quality Representative on complex investigations, contributing to robust and compliant decision-making processes.
• Foster consistent product quality and patient safety by supporting batch review and Product Safety Incident Management activities.
• Collaborate closely with team members, Associate Director, Integrated Process Team colleagues, and shift teams to drive operational excellence.
• Represent Quality Assurance Integrated Process Team at Quality and cross-functional tier meetings, ensuring alignment across functions.
• Build and maintain strong relationships across Quality, Operations, and support functions for seamless collaboration.
• You'll coach and mentor direct reports, supporting their development and upskilling, engaging in meaningful one-on-ones, mid-year, and end-of-year reviews.
• Work with team members to deliver Continuous Improvement projects, standard work initiatives, and comprehensive training programs.
• Champion a safe, compliant, high-performance, and inclusive culture within the team.
• Drive the completion of key projects and support the site’s goals through effective teamwork.
• Ensure day-to-day compliance with Current Good Manufacturing Practice/Good Documentation Practice activities, regulatory requirements, and corporate standards.
• Uphold Data Integrity principles in all documentation and recordkeeping.
• You'll participate in internal and external audits as auditee for assigned areas, contributing to quality assurance.
• Lead or support quality-related projects aimed at improving quality reporting measures.
• Contribute to documentation review, investigation writing, and Corrective and Preventive Action management.
• Liaise with Quality Specialists, Quality Assurance Lead, Qualified Person, and Business Area Specialists to resolve quality queries efficiently.
• Influence and support compliance initiatives to enhance batch release performance and operational efficiency.
• Ensure effective communication channels are established across teams and organizational levels.
• Act as an advocate for continuous improvement within our Quality Management System.
• Perform other duties as assigned in support of department and site priorities.

Skills you will bring

• You hold a degree or higher in a Science-based discipline.
• Minimum of 5 years’ experience in the pharmaceutical industry, showing your dedication and expertise.
• Sterile manufacturing experience is essential, making you a perfect fit for our team.

• Existing People Management experience is a distinct advantage, showcasing your leadership skills.

Our facility in 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

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. 

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. 

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. 

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. 

Please feel free to speak to us about what flexibility means to you during your application. 

So, if you are ready to: 

Invent solutions to meet unmet healthcare needs, please apply today. 

Required Skills:

Accountability, Analytical Problem Solving, cGMP Compliance, Decision Making, Documentation Review, Driving Continuous Improvement, Leadership, Operational Excellence, Problem Solving, Quality Assurance (QA), Troubleshooting

Preferred Skills:

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:

04/27/2026

*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.