Associate Director, Supplier Quality Assurance (FTC - 2 Years)
Join MSD Animal Health UK Ltd as an Associate Director, Supplier Quality Assurance on a Fixed Term Contract for two years. This role is part of the Quality Technical Expertise and Compliance Team and will play a key role in safeguarding product quality, regulatory readiness and patient safety.
Job Description
MSD Animal Health is a research‑intensive biopharmaceutical company at the forefront of science. The Associate Director, Supplier Quality Assurance will lead external partner manufacturing of active drug substances, ensuring suppliers comply with GMP, regulatory requirements, and our Quality Manual.
Responsibilities
* Lead end‑to‑end supplier quality oversight from due diligence, selection, facility design review, process development, validation, technology transfer, commercial supply, to continuous improvement.
* Maintain and update Quality Agreements, ensuring suppliers operate in accordance with GMP policies, the Quality Agreement and commercial agreements.
* Plan and conduct on‑site and remote audits, produce evidence‑based reports and drive timely, effective CAPA and verification of effectiveness.
* Ensure supplier compliance with EU, FDA and other global regulatory bodies, Annex 1 sterile standards and our Quality Manual.
* Support implementation and assessment of supplier Quality Management Systems, including change control, deviations, CAPA, OOS/OOT investigations and document control.
* Review contamination control, sterility assurance, utilities, environmental monitoring and qualification/commissioning strategies.
* Lead technical investigations into deviations, OOS/OOT, microbiological excursions, stability or complaint events, ensuring root‑cause analysis, remediation and regulatory reporting.
* Review, approve and manage supplier change controls; coordinate regulatory impact assessments with crossfunctional stakeholders.
* Monitor supplier performance through KPIs and periodic quality reviews, identify trends and implement systemic corrective/preventive actions.
* Serve as the primary quality interface with suppliers and internal stakeholders across technical, regulatory, procurement and manufacturing sites, and represent MSD during regulatory engagements.
* Identify and escalate critical quality or supply‑continuity risks to senior management with clear, actionable recommendations.
* Coach, influence and build capability in supplier and internal teams to strengthen quality culture and sustained compliance.
* Operate effectively in a global, virtual, matrixed environment; travel to supplier sites as required and keep the Director informed of status, opportunities and issues.
Qualifications
Required
* Bachelor’s degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering or equivalent.
* Broad experience in Quality Systems, Quality Assurance and Quality Control, including solid knowledge of global GMP and regulatory requirements.
* English language capability; a second language is preferred.
* Excellent problem‑solving skills based on science, facts, data and regulatory understanding in complex evolving environments; apply sound risk‑management principles.
* Ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
* Expertise in pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs, and regulatory issues.
* Independent work with limited supervision in a virtual‑management environment.
* Strong interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non‑routine matters in stressful situations.
Preferred
* Qualified Person eligibility if located in Europe.
* Experience performing audits of external and internal manufacturers and testing laboratories.
* Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
* Demonstrated ability to lead and drive results/impact for critical business/compliance initiatives.
* Demonstrated ability for process improvement and to create/implement simple, compliant systems in diverse areas.
* Experience with direct participation on interdisciplinary due diligence teams with senior management.
EEO Statement
MSD Animal Health is an equal‑opportunity employer. Our workforce is built on diversity, inclusion and a commitment to fostering an environment where all employees can thrive.
Job Location
Milton Keynes, England, United Kingdom
Job Posting End Date
11/27/2025
Remote Work
Remote arrangements are permitted where role requirements allow.
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