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Director, quality assurance – value chain management

MSD
Manager
Posted: 13 November
Offer description

Job DescriptionWe're looking for aDirector of Quality Assuranceto lead quality across the full value chain for a late‑stage ophthalmic program. In this role, you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance, and enabling manufacturing excellence from development through commercialization. You'll partner across Quality, Regulatory, Technical, and Supply Chain teams—coaching, facilitating, and removing obstacles so the program can thrive.Bring energy, knowledge, innovation to carry out the followingOwn the product's quality strategy, aligned to supply strategy, and ensure clear documentation and executionShape the analytical strategy (labs, testing approaches, stability) and support site selectionProvide hands‑on quality leadership to product and focus teams; advise, problem‑solve, and drive continuous improvementImplement and oversee fit‑for‑purpose Quality Management Systems and standard ways of workingStay current on regulations and apply them pragmatically; support inspections and champion ongoing inspection readinessPartner with Corporate Quality and other sites to share best practices and align on quality systemsLead quality communications across the network; run meetings, surface risks, and escalate issues when neededTrack and interpret key metrics (changes, complaints, annual product reviews) to identify trends and mitigate riskReview and approve cross‑site evaluations and post‑marketing assessmentsMonitor franchise quality risks and performance with site quality teamsRepresent Quality on the Value Chain Management Team and related working groups; lead or contribute to chartered projectsWhat Skills You Will NeedIn order to excel in this role, you will more than likely have10+ years in the pharmaceutical industry with proven leadership experienceDeep quality expertise; experience with ophthalmic or large molecules is a plusBackground in continuous improvement or analytics is helpfulStrong project management, communication, and stakeholder skillsExperience leading cross‑functional teams to deliver on strategic initiativesDegree in a science, pharmacy, or engineering discipline; advanced degree welcomeTrack record of driving change and measurable improvementsCommitment to professional growth and continuous learningCollaborative mindset and ability to build trust across diverse teamsTravel requirementWillingness to travel 10-15% for assignments outside your primary location, including short-term travel as neededWe keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.Please feel free to speak to us about what flexibility means to you during your application.So, if you are ready toInvent solutions to meet unmet healthcare needs,please apply today.Required SkillsCommunication, Entrepreneurship, Execution Excellence, Influence, Leadership, Networking and Partnerships, Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance, Risk Management, Stakeholder ManagementPreferred SkillsCurrent 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 StatusRegularRelocationVISA SponsorshipTravel RequirementsFlexible Work ArrangementsHybridShiftValid Driving LicenseHazardous Material(s)Job Posting End Date11/26/2025A job posting is effective until PM 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 IDR372886

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