Compliance Manager, Clinical Supply Chain

Compliance Manager, Clinical Supply ChainAt Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:We're looking for a Compliance Manager, Clinical Supply Chain on the Clinical Supply Chain team to help us expand what's possible for patients with serious diseases. Reporting to the Director, Clinical Supply Chain, you'll be responsible for managing compliance activities throughout the supply chain for assigned studies and projects ranging from phase I to phase IV clinical studies.What You'll Do:In this role, you'll have the opportunity to ensure audit readiness for potential inspections to support the Clinical Supply Chain and Technical Operations and serve as main point of contact for compliance within the clinical supply on designated studies and projects function. You'll also:Assist in developing the TMF index to better support the supply chain for assigned studies and/or programsSupport IRT system design and UAT requirements for assigned studies. Perform UAT testing on IRT systemsSupport Change Control management activities within the clinical supply chainCoordinate with and manage external packaging, labeling and distribution vendorsRepresent Supply Chain & Logistics at cross-functional study level meetings to ensure timely updates and information to assigned studies/projectsCommunicate relevant project information to internal and external stakeholdersDevelop and present slide decks, coordinate drafting of reports, and edit documents for preparation of business development activitiesIdentify, report, manage and mitigate risks in the clinical supply chainProvide regular updates to the TMF as per regulatory requirementsUnderstand internal stakeholders to ensure supply compliance at each node within the supply chainCoordinate with Supplier Relationship Management for clinical suppliers, including maintaining key performance metricsCoordinate with Insmed contracted clinical supply organizations to appropriately disposition clinical supply materialDraft SOPs, WPs and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirementsWork closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable resultsResponsible for managing the groups training curriculumWho You Are:You have a bachelor's degree along with 5+ years of experience in drug development, clinical supply chain management and/or clinical manufacturing operations.You are or you also have:Ability to identify risksin process management and develop a solution-based approach that is operationally achievableProficient with Microsoft Applications (Excel, PowerPoint, Word)Experience working with and/or managing external vendorsWorking knowledge of GMP, GCP and ICH guidelinesStrong teamwork and collaboration skillsStrong ability to handle multiple projects simultaneouslyAct with a sense of urgencyNice to have (but not required):MS Project and other computer software demand & supply related systems are a plusWhere You'll WorkThis is a hybrid role based out of our Bridgewater, NJ office. You'll have the option to work remotely most of the time, with in-person collaboration when it matters most.Travel RequirementsThis role requires occasional global travel (approximately 5%–15%)Pay Range:$124,000.00-161,000.00 AnnualLife at InsmedAt Insmed, you'll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.Highlights of our U.S. offerings include:Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insuranceCompany Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunitiesEmployee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give backEligibility for specific programs may vary and is subject to the terms and conditions of each plan.