Associate Director, Supplier Quality Assurance

Job DescriptionAt our company we aspire to be the premier research-intensive biopharmaceutical company. Were 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.ResponsibilitiesServe 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.QualificationsRequiredBachelors degree in Veterinary Chemistry Pharmacy Biology Microbiology Chemical Engineering or equivalentExpertise and broad experience in Quality Systems Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirementsEnglish language capability preferably with a second languageExcellent 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 principlesAbility to influence management of complex manufacturing operations protecting company image and reputation with patients medical stakeholders and regulatory agenciesExpertise in interdisciplinary areas of pharmaceutical sciences analytical chemistry microbiology sterile operations cGMPs and regulatory issuesAbility to work independently with limited supervision in a virtual-management environmentStrong 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 ambiguityPreferredQualified Person eligibility if located in EuropePerforming audits of external and internal manufacturers and testing laboratoriesDemonstrated ability to establish and maintain collaborative relationships with key stakeholdersDemonstrated ability to lead and drive results/impact for critical business/compliance initiativesDemonstrated ability for process improvement and to create/implement simple compliant systems in a diversity of areasExperience with direct participation on interdisciplinary Due Diligence teams with Senior Management inclusive of initial risk/compliance assessment based on documentationWe 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 anothers 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 ManagementPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & 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:RemoteShift: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 BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Required Experience:Director Key Skills Quality Assurance,FDA Regulations,ISO 9001,Root cause Analysis,Biotechnology,Clinical Trials,Quality Systems,Food Processing,Quality Control,Quality Management,cGMP,HACCP Employment Type : Full-Time Experience: years Vacancy: 1