Associate Director, Quality Control

Merck Gruppe - MSD Sharp & Dohme; Ireland; On-site; EUR 120,000 - 170,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Carlow, Ireland, seeks an Associate Director of Quality Control to lead Bioassay and Chemistry teams responsible for testing, stability, and release samples for site and partner networks.

The role provides expert analytical support, regulatory compliance leadership, and drives continuous improvement across QC with significant leadership responsibilities.

Qualifications

• 10+ years’ experience in the pharmaceutical industry with leadership exposure.
• Third-level/science degree (Biochemistry, Chemistry, Biosciences) or equivalent.
• Solid grasp of GMP/GLP regulations and QC testing workflows.

Responsibilities

• Lead, coach, and develop managers and senior team members within QC.
• Ensure lab KPIs align with site goals and supply targets.
• Oversee laboratory readiness for new product introductions.
• Ensure compliance with regulatory requirements and foster safety/quality culture.
• Drive continuous improvement and Lean initiatives, including digital tools.
• Manage QC budget and liaise with global partners on transfers.

Skills

Leadership

GMP Compliance

Analytical Method Development

Lean Six Sigma

Quality Leadership

Regulatory Requirements

Biochemistry

Biological Sciences

Analytical Testing

People Leadership

Education

Science degree (Biochemistry/Chemistry/Biosciences)

Job description

Job Description

An exciting opportunity to join our Carlow site as an Associate Director of Quality Control. The Associate Director of Quality Control (QC) will play a pivotal leadership role, overseeing the Bioassay and Chemistry teams responsible for testing, stability, and release samples for the site and supporting partner and sister sites.

This position also provides expert analytical support, including analytical investigations and analytical transfers, while driving compliance, operational excellence, and continuous improvement across the QC function.

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

• Leading, developing, coaching, and supporting managers and senior team members within the quality control department.
• Align site deliverables with department goals and objectives.
• Ensure lab KPIs are achieved to support supply targets.
• Oversee laboratory readiness for new product introductions.
• Ensure compliance with global and regulatory requirements, promoting a strong culture of safety and quality.
• Manage QC-related issues, including atypical results, out-of-specification investigations, and significant quality investigations.
• Drive continuous improvement initiatives, including the adoption of digital technologies to improve efficiency.
• Collaborate with cross-functional site teams, including QC Operations, IPT, Automation Compliance, Regulatory, Technical Engineering, and C&Q teams, to ensure regulatory requirements are met.
• Manage laboratory budget and costs, ensuring financial targets are achieved.
• Liaise with global partners on technical transfer and validation strategies.
• Implement and sustain continuous improvement programmes, Lean principles, and Lean thinking.

Skills you will bring:

• Strong analytical aptitude and critical thinking skills.
• Ability to apply key scientific and technical concepts effectively.
• Proven ability to develop talent through strong mentoring and coaching.
• In-depth knowledge of GMP and GLP regulations.
• Knowledge of analytical validation and transfer requirements.
• Strong Lean Six Sigma experience.
• 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 site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines,biologicsand small molecule drug product.Since itsinitiallaunch, the site has attracted significant internal investment and is now home toa number ofstate-of-the-artproduction facilities,laboratoriesand temperature-controlled warehousing units. The Carlow site is a significant employer in theSouth Eastregion 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.

Pleasedon'thesitate 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:

Required Skills:

• Adaptability
• Adaptability
• Analytical Method Development
• Bioanalytical Method Development
• Biochemistry
• Biogeochemistry
• Biological Sciences
• Biomedical Sciences
• Biostatistics
• Driving Continuous Improvement
• GMP Compliance
• Immunochemistry
• Instrumentation
• Laboratory Management
• Lean Six Sigma (LSS)
• Manufacturing Compliance
• Method Development
• New Product Introduction Process
• People Leadership
• Pharmaceutical Management
• Phytochemistry
• Quality Leadership
• Quality Standards
• Regulatory Requirements
• Strategic Thinking {+ 1 more}

Preferred Skills:

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

Requisition ID: R410792