Associate Director, Quality Assurance (Quality Management System)

MSD Malaysia; Blackrock; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

MSD Malaysia is seeking an inspiring leader to shape and champion our laboratory Quality Management System across international sites, harmonising procedures, simplifying documentation and fostering a collaborative culture of compliance.

You will partner with laboratory managers and technical teams to implement ISO 17025-aligned controls, manage audits and CAPA programmes, monitor quality performance and drive continuous improvement across Newport, Dublin and Lawrence.

Qualifications

• 5+ years of quality experience within an accredited environment, preferably a scientific testing laboratory.
• Bachelor’s degree in a scientific discipline; advanced degree or quality certification preferred.
• Strong expertise with ISO 17025, ISO 9001 or comparable lab-quality frameworks.

Responsibilities

• Lead the multi-site laboratory Quality Management System, ensuring alignment with ISO 17025 or comparable standards.
• Partner with laboratory managers to define, harmonise and maintain quality procedures and controls.
• Serve as liaison with global accreditation bodies, managing audits, corrective actions and cycles.
• Maintain documentation control, change management and internal audit programmes.
• Monitor quality performance, analyse trends and provide KPI reporting to senior leadership.
• Apply risk-based quality principles to identify vulnerabilities and strengthen processes.
• Drive continuous improvement initiatives and ensure standardised adoption across labs.
• Provide leadership, coaching and training to site Quality Representatives.
• Support integration of new technologies and digital tools into the quality framework.

Skills

ISO 17025 expertise

Lead Auditor certification

Quality metrics analysis

Audit management

Cross-functional collaboration

Travel willingness

Education

Bachelor's degree in a scientific discipline

ASQ/Lead Auditor certification

Job description

Job Description For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technologies. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one does it like we do. We are looking for an inspiring leader to shape and champion our laboratory Quality Management System across our international sites. In this role, you will collaborate closely with our talented laboratory managers and technical teams to harmonise our quality procedures, simplify documentation practices and foster a collaborative culture of compliance.

Responsibilities

• Lead the multi-site laboratory Quality Management System, ensuring alignment with ISO 17025 or comparable standards, corporate quality expectations and consistent implementation across sites in Newport (UK), Dublin (IRL) and Lawrence (Kansas-USA)
• Partner with laboratory managers and technical teams to define, harmonise and maintain quality procedures, documentation practices and compliance controls
• Serve as the primary liaison with global accreditation bodies and third-party auditors, managing audit readiness, corrective actions and accreditation cycles
• Maintain and improve documentation control, change management and internal audit programmes
• Monitor quality performance across sites, analyse trends and provide KPI reporting to senior leadership
• Apply risk-based quality principles to identify vulnerabilities, prioritise action, and strengthen processes
• Drive continuous improvement initiatives, evaluating the effectiveness of implemented changes and ensuring standardised adoption across labs
• Provide functional leadership, coaching and training to site Quality Representatives to build quality capability and ensure consistent practices across locations
• Support integration of new technologies, methods and digital tools into the quality framework as the lab network evolves
• Stay current with global certification requirements, industry best practices and trends in scientific testing quality systems

Required Skills

• 5+ years of quality experience within an accredited environment, preferably a scientific testing laboratory
• Bachelor’s degree in a scientific discipline required; advanced degree or quality certification (e.g., ASQ, Lead Auditor) preferred
• Strong expertise with ISO 17025, ISO 9001 or comparable lab-quality frameworks
• Proven experience managing external audits, accreditation activities, CAPA programmes and continuous improvement efforts
• Strong analytical skills with experience generating and interpreting quality metrics, audit results and operational data
• Excellent collaboration and stakeholder‑management skills in a highly cross-functional environment
• Demonstrated ability to train teams, influence without direct authority and support a global or multi-site structure
• Willingness to travel internationally 15-20%

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.

The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.

We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

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.