Director Quality Control

Job Description

An exciting opportunity to join our Carlow site as Director of Quality Control. The Director of Quality Control is responsible for the direction and management of the Quality Control laboratories at Carlow to ensure compliant laboratory testing and provide the highest quality analytical support for manufacturing, while ensuring compliance with cGMP and safety regulations. This is a critical role within the Quality Leadership Team to help create value for our patients.

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

• Strategic Quality Control oversight and leadership to meet functional and site goals and objectives.
• Responsible for Quality Control related testing for the Carlow site as well as the wider network.
• Hire, develop, lead and coach the next level Quality Control leadership team and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Responsible for adhering to domestic and international GMP regulations, cGMP, company policies, leadership behaviours, performance and budget management.
• Build safety as a value within the Quality Control teams and maintain sustainable EHS programmes that are embedded within the department.
• Responsible for Quality Control oversight and compliance of laboratory related commissioning, qualification and validation activities.
• Responsible for ensuring that the Quality Control laboratory test methods are qualified/validated as per corporate and site procedures.
• Provide guidance to all relevant quality related events and direction to develop the area’s technical and compliance capability along with long term strategic planning.
• Maintain all laboratories in an inspection-ready, GMP-compliant state.
• Ensure Quality Control-owned business systems are established and engage with the business systems owner to continually improve processes.
• Lead the Quality Control department in meeting targeted site and Quality objectives, ensuring department objectives are aligned, translated to all and visually managed to drive delivery and efficiencies.
• Sustain performance through lean leadership, robust learning and development planning, organisation talent reviews and communication planning. Build partnerships within the Quality leadership team to create and sustain a culture that demonstrates excellence in quality and continuous improvement.
• Create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
• Responsible for individual goal setting, ongoing performance reviews and development planning for direct reports and function.
• Accountable for the department budget and operational spend.
• Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross-functionally on resolving obstacles.
• Responsible for ensuring compliance with legal, EHS and all policies and procedures which are applicable to the site.

Skills You Will Bring:

• Proven leadership experience in a Quality Control or similar regulated laboratory environment.

• Strong knowledge of domestic and international GMP regulations and cGMP requirements.

• Experience overseeing laboratory testing, commissioning, qualification and validation activities.

• Strong understanding of EHS principles and compliance requirements.

• Experience driving continuous improvement through Lean principles and operational excellence.

• Ability to provide strategic direction while maintaining operational effectiveness.

• Strong analytical, compliance and problem-solving skills.

• Third-level qualification in a science-related discipline, ideally Biochemistry, Chemistry, Biosciences, or equivalent.

• Analytical testing experience in a pharmaceutical laboratory.

• 10+ years’ experience in the pharmaceutical industry, including significant leadership experience and front-line supervisory experience in an operations environment.

Our facility in Carlow 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:

Analytical Instrumentation, Analytical Instrumentation, Biological Analysis, Budget Management, Business Systems, Chemical Analysis, Coaching Feedback, Driving Continuous Improvement, GMP Compliance, Goal Setting, Key Client Relationships, Laboratory Testing, Lean Leadership, Microbiological Analysis, Organizational Culture, Organizational Planning, People Leadership, Process Improvements, QA Leadership, Qualitative Testing, Quality Control Management, Quality Improvement Programs, Quality Management, Quantitative Assay, Software Quality Control {+ 1 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/27/2026

*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.