Associate Director, External Quality

Job Description

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 handson technical support riskbased 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 auditready performance.

Responsibilities:

Serve as Animal Health Quality Lead for external partners manufacturing active drug substances including sterile and biologic products.

Provide endtoend 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 riskbased tools; plan and lead onsite and remote audits produce evidencebased 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 rootcause analysis remediation and regulatory reporting where required.

Review approve and manage supplier change controls and coordinate regulatory impact assessments with crossfunctional 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 supplycontinuity 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

Bachelors 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 APIs 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 APIs 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:

Preferred Skills:

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