Compliance Manager, Clinical Supply Chain

At 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 programs Support IRT system design and UAT requirements for assigned studies. Perform UAT testing on IRT systems Support Change Control management activities within the clinical supply chain Coordinate with and manage external packaging, labeling and distribution vendors Represent Supply Chain & Logistics at cross-functional study level meetings to ensure timely updates and information to assigned studies/projects Communicate relevant project information to internal and external stakeholders Develop and present slide decks, coordinate drafting of reports, and edit documents for preparation of business development activities Identify, report, manage and mitigate risks in the clinical supply chain Provide regular updates to the TMF as per regulatory requirements Understand anernal stakeholders to ensure supply compliance at each node within the supply chain Coordinate with Supplier Relationship Management for clinical suppliers, including maintaining key performance metrics Coordinate with Insmed contracted clinical supply organizations to appropriately disposition clinical supply material Draft SOPs, WPs and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results Responsible for managing the groups training curriculum Who 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 risks in process management and develop a solution-based approach that is operationally achievable Proficient with Microsoft Applications (Excel, PowerPoint, Word) Experience working with and/or managing external vendors Working knowledge of GMP, GCP and ICH guidelines Strong teamwork and collaboration skills Strong ability to handle multiple projects simultaneously Act with a sense of urgency Nice to have (but not required): MS Project and other computer software demand & supply related systems are a plus Where You’ll Work This 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 Requirements This role requires occasional global travel…

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