Associate Director, Quality Control

MSD

Carlow

Hybrid

EUR 120,000 - 190,000

Full time

14 days+
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Job summary

MSD is seeking an Associate Director of Quality Control at its Carlow site. The role leads Bioassay and Chemistry teams, oversees testing, stability, and release samples, and provides expert analytical support for investigations and transfers.

The successful candidate will drive GMP compliance, Lean initiatives, and cross-functional collaboration with regulatory, IPT, and C&Q teams, while managing budget and Lean-based process improvements.

Qualifications

  • Broad expertise in analytical and bioanalytical method development.
  • Strong GMP/GLP understanding and adherence to regulatory standards.
  • Proven ability to lead and mentor managers and technical staff.

Responsibilities

  • Lead, develop, coach, and support QC managers and staff.
  • Ensure KPIs and site deliverables align with department goals.
  • Drive continuous improvement and adoption of digital technologies in QC.

Skills

Analytical Methods
Bioanalytical Methods
Biochemistry
GMP Compliance
Lean Six Sigma
People Leadership
Regulatory
Laboratory Mgmt
Method Development

Education

Science degree

Tools

Instrumentation

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.

Responsibilities
  • 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, 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.

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.

Required Skills
  • Adaptability
  • Adaptability
  • Analytical Method Development
  • Bioanalytical Method Development
  • Biochemistry
  • Biogeochemistry
  • Biological Sciences
  • Biomedical Sciences
  • Biostatistics
  • Driving Continuous ImprovementGMP Compliance
  • Immunochemistry
  • Instrumentation
  • Laboratory Management
  • Lean Six Sigma (LSS)
  • Manufacturing Compliance
  • Method Development
  • New Product Introduction Process
  • People Leadership
  • Pharmaceutical Management
  • PhytochemistryQuality Leadership
  • Quality Standards
  • Regulatory Requirements
  • Strategic Thinking
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