Compliance Manager, Clinical Supply Chain

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 internal 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 (approximately 5%–15%)