Associate Director, Quality Control

MSD Malaysia; Carlow; Hybrid; EUR 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid working model

Flexible working potential

Job summary

MSD Malaysia invites applications for an Associate Director of Quality Control at our Carlow site. This senior role leads Bioassay and Chemistry teams responsible for testing, stability and release samples, and provides expert analytical support across QC functions.

The successful candidate will drive compliance, continuous improvement, and Lean Six Sigma initiatives, mentor managers, manage budgets, and collaborate with cross-functional teams to meet regulatory requirements and delivery targets.

Qualifications

• 10+ years in the pharmaceutical industry with leadership experience.
• Third-level qualification in science (Biochemistry/Chemistry or related).
• Strong GMP/GLP knowledge and analytical testing experience.

Responsibilities

• Lead, develop, and coach managers and senior staff in QC.
• Ensure site deliverables align with department goals and KPIs.
• Oversee lab readiness for new products and regulatory readiness.
• Drive compliance, investigations, and continuous improvement.
• Manage QC budgets and collaborate with cross-functional teams.
• Liaise with partners on tech transfer and validation.

Skills

Leadership

GMP knowledge

Lean Six Sigma

Analytical testing

Regulatory knowledge

Biochemistry

Analytical validation

People leadership

Education

Bachelor's degree in a science-related discipline

Tools

Analytical instruments

LIMS

Quality management systems

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, 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.

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

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}

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.