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Associate Director, Quality Assurance; Quality Management System

Job in Northern, Floyd County, Kentucky, USA
Listing for: MSD Malaysia
Full Time position
Listed on 2026-10-05
Job specializations:
  • Quality Assurance - QA/QC
    QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, Quality Engineering
Salary/Wage Range or Industry Benchmark: 110000 - 170000 USD Yearly USD 110000.00 170000.00 YEAR
Job Description & How to Apply Below
** 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  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.
** Bring energy, knowledge, innovation to carry out the following:
*** 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
** What skills you will need:
** In order to excel in this role, you will more than likely have:
* 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. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible…
Position Requirements
10+ Years work experience
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