Associate Director, External Quality Full Time

Employment Type FIXED TERM CONTRACT

Contract Duration 3 years

The primary purpose of this role is to lead quality assurance for external suppliers of sterile and biologic manufacturing. You will drive supplier selection and qualification, audits, QMS implementation, process validation, and deviation/OOS management, ensuring regulatory compliance (EU, FDA, Annex 1) while collaborating globally to safeguard product quality, regulatory readiness and patient safety.

You will ensure that all externally supplied products and materials are manufactured, packaged, analysed and distributed in full conformance with Animal Health policies and applicable regulatory requirements, and meet internal and external customer expectations. This is achieved through hands‑on technical support, risk‑based guidance and practical coaching of supplier quality representatives. The incumbent influences and mentors suppliers to implement robust, compliant systems and processes, ensuring adherence to cGMP and other legal obligations and enabling sustained, audit‑ready performance.

Responsibilities

• Serve as Animal Health Quality Lead for external partners manufacturing active drug substances, including sterile and biologic products.
• Provide end‑to‑end supplier quality oversight from due diligence and selection through facility design review, process development, validation, technology transfer, commercial supply and continuous improvement.
• Ensure suppliers operate in accordance with agreed GMP policies, the Quality Agreement and the Quality elements of Commercial Agreements; maintain and update Quality Agreements as required.
• Assess supplier capabilities and compliance using risk‑based tools; plan and lead on‑site and remote audits, produce evidence‑based reports, and drive timely, effective CAPA and verification of effectiveness.
• Ensure supplier compliance with global regulations (EU, FDA and other major authorities), Annex 1 sterile standards, and Quality Manual requirements.
• Support implementation and assessment of supplier Quality Management Systems (change control, deviations, CAPA, OOS/OOT investigations, document control, training, internal audits, management review).
• Review and influence contamination control, sterility assurance, utilities, environmental monitoring and qualification/commissioning strategies.
• Lead technical investigations into deviations, OOS/OOT, microbiological excursions, stability or complaint events; ensure rigorous root‑cause analysis, remediation and regulatory reporting where required.
• Review, approve and manage supplier change controls and coordinate regulatory impact assessments with cross‑functional stakeholders.
• Monitor supplier performance via KPIs and periodic quality reviews; identify trends and implement systemic corrective/preventive actions.
• Act as primary quality interface with suppliers and internal stakeholders (Technical, Regulatory, Procurement/Supply Chain, AH using sites) and represent 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 and travel to supplier sites as required; keep the Director informed of status, opportunities and issues.

Required

• Bachelor’s degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or equivalent
• Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
• Must have English language capability preferably with a second language
• Must have excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles
• Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
• Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, biotechnology, sterile operations, cGMPs and regulatory issues
• Must have the ability to work independently with limited supervision in a virtual-management environment.
• Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organizational complexity and ambiguity

Preferred

• Advantageous to have Qualified Person eligibility if located in Europe
• 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 a diversity of areas.
• Experience with direct participation on interdisciplinary Due Diligence teams with Senior Management, inclusive of initial risk/compliance assessment based on documentation.

Leadership Behaviors

• Focus on Customers and Patients
• Make Rapid, Disciplined Decisions
• Act with Courage and Candor
• Build Talent
• Demonstrate Ethics and Integrity
• Drive Results
• Foster Collaboration

Your profile

• Minimum of 8 years of manufacturing, technology, and/or quality operation experience within an EU/FDA, API, Drug Product, Medical Device or equivalent environment.
• Quality/compliance experience in an EU/FDA regulated industry.
• Experience performing audits of external and internal manufacturers and testing laboratories.
• Thorough understanding of Quality Management Systems and process to support the manufacturing of API’s, drugs products, and medical devices, including risk management.
• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
• Ability to work independently with limited supervision in a virtual-management environment.
• Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination product, Biologics, Vaccines, API’s, Non-sterile Drug Product or Sterile Drug Product manufacture.
• Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization
• Must have the ability to travel globally approximately 25% of the time.

Required Skills

Adaptability, Adaptability, Analytical Chemistry, Bioanalysis, Chemical Engineering, Communication, Contamination Control, Decision Making, Deviation Management, Environmental Monitoring, GMP Compliance, Interpersonal Relationships, Medical Devices, Process Improvements, Procurement, Quality Agreements, Quality Assurance (QA), Quality Control (QC), Quality Control Management, Quality Management Systems (QMS), Regulatory Compliance, Regulatory Compliance Audits, Risk Management, Stakeholder Relationship Management, Strategic Thinking {+ 1 more}

Preferred Skills

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Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Project Temps (Fixed Term)

Relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License

Hazardous Material(s)

Job Posting End Date

06/18/2026

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID R398750