Associate Director, Quality Control

Merck Gruppe - MSD Sharp & Dohme; Carlow; Hybrid; EUR 120,000 - 150,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Carlow, Ireland, seeks an experienced QC leader to drive quality, safety, and regulatory compliance in a biologics and vaccine manufacturing setting.

The role focuses on leading managers, aligning site deliverables with department goals, and ensuring KPIs support supply targets while overseeing new product introductions and continuous improvement initiatives.

Qualifications

• In-depth knowledge of GMP and GLP regulations.
• Strong leadership and talent development capabilities.
• Experience overseeing QC operations and regulatory alignment.
• Experience with continuous improvement and Lean principles.

Responsibilities

• Lead, develop, coach, and support managers and senior team members in QC.
• Ensure lab KPIs align with site goals and supply targets.
• Oversee laboratory readiness for new product introductions.
• Maintain compliance with global and regulatory requirements for safety and quality.
• Manage QC issues including investigations and atypical results.
• Drive digital and Lean initiatives to improve efficiency.
• Collaborate with cross-functional site teams to meet regulatory requirements.

Skills

Lean Six Sigma

GMP/GLP knowledge

Leadership

Mentoring & coaching

Analytical testing

Regulatory requirements

Strategic thinking

Education

Science degree (Biochemistry/Chemistry/Biosciences)

Job description

Location Carlow, Carlow, Ireland Job Type Full time

Job Description

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.
• 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-advanced production 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.

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.

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}

Job Description

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.
• Strong Lean Six Sigma experience.

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-advanced production 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.

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.

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}

Employee Status: Regular

Flexible Work Arrangements: Not Applicable

Job Posting End Date: 10/19/2026

Requisition ID: R410792