Associate Director, Supplier Quality Assurance

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join us in our mission to safeguard product quality, regulatory readiness, and patient safety as Associate Director, Supplier Quality Assurance (Fixed Term Contract - 2 years) within our Quality Technical Expertise and Compliance Team.

• Serve as our company 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 our company 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, our company manufacturing sites) and represent our company 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
• Expertise and broad experience in Quality Systems, Quality Assurance, and Quality Control including solid knowledge of global GMP and regulatory requirements
• English language capability, preferably with a second language
• Excellent problem-solving skills, based on science, facts, data, and understanding of the regulatory requirements in complex and evolving environments; ability to 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 interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs, and regulatory issues
• Ability to work independently with limited supervision in a virtual-management environment
• 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

• Qualified Person eligibility if located in Europe
• 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 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

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Required Skills:

Commercial Agreements, Decision Making, GMP Compliance, Interpersonal Relationships, Management Process, Process Improvements, Quality Agreements, Quality Assurance (QA), Quality Management Systems (QMS), Regulatory Compliance, Regulatory Compliance Audits, Risk Management, Stakeholder Relationship Management, Strategic Thinking, Supplier Management, Supplier Quality Management

Preferred Skills:

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Current Contingent Workers apply HERE

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:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/27/2025

• 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:R371931