Associate Director, IT Compliance Applications

Insmed Inc. • Bridgewater, NJ • 5h ago

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:This role serves as the IT System Owner for the Learning Management System and compliance IT systems, which includes supporting GxP-regulated applications, while also functioning as strategic IT business partner for Compliance. The position requires a blend of technical expertise and business acumen to ensure regulatory compliance, system integrity, and alignment with business objectives across multiple IT platforms.What You'll Do: In this role, you'll have the opportunity to be a Compliance IT Business Partner & IT System Owner. You'll also Act as strategic IT business partner for the Compliance department, serving as the primary IT liaison for their technology needs Serve as primary liaison between vendors and business for the supported systems Align IT initiatives with business strategy and priorities across all technology solutions Support business requirements gathering for system enhancements and new system implementations Provide ongoing IT support and consultation for business processes and technology needs Collaborate with business to identify technology opportunities and solutions that support business objectives Serve as the designated IT System Owner for the Learning Management System and compliance IT systems Drive compliance as IT system owner of the application, supporting internal and external audits to ensure regulatory compliance Manage technical ownership, change control, and documentation while ensuring system integrity and regulatory adherence throughout the system lifecycle Ensure systems meet business needs and operational requirements while being responsible for technical stability, system administration, and maintenance across the technology portfolio Maintain systems changes, releases, and patches; review system releases and patches for impact across multiple systems Ensure that System Administration and Maintenance SOPs are created/updated as appropriate for all managed systems Oversee technical implementation, integration, and optimization of multiple systems, ensuring alignment with business objectives Collaborate closely with cross-functional teams including Quality Assurance, IT, CSV, and Compliance departments Ensure that Disaster Recovery meets the requirements of the businessWho You Are: Bachelor's degree in Computer Science, Information Technology, or related field 7+ years of experience in IT with specific focus on Compliance-related systems Technical knowledge of LMS applications, compliance business, and IT infrastructure Previous experience managing computer systems in pharmaceutical environments Knowledge of System Operational procedures and methodologies across various system @types Excellent leadership, communication, and problem-solving skills Proven ability to serve as IT partner and manage multiple system portfolioNice to have (but not required) Experience with ComplianceWire/UL,Veeva Vault, and other similar software platforms Knowledge of 21 CFR Part 11, Electronic Records and Electronic Signatures Experience with GAMP 5 guidelines and validation lifecycle processes IT System Project management * Experience managing vendor relationships for multiple software platformsWhere You'll WorkThis is a hybrid role based out of our Bridgewater NJ HQ office. You'll ha

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