Sr Manager, IT Clinical Systems Validation

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:We're looking for a Sr Manager, IT Clinical Systems Validation in the IT team to help us expand what's possible for patients with serious diseases. Reporting to the Director, Clinical Systems & Business Intelligence, you'll be responsible to provide the necessary expertise to validate and maintain the validated state of our expanding technology landscape ensuring the highest standards of regulatory compliance and data integrity.What You'll Do: In this role, you'll have the opportunity to lead the planning, execution, and documentation of computer system validation (CSV) activities for clinical applications. You'll also: Create integrations between systems, change controls, periodic reviews, and revalidation efforts throughout the system lifecycle. Collaborate with business owners, QA, and CSV teams to ensure validation deliverables meet GxP and regulatory compliance standards. Author and/or review validation documentation including Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ), etc. Evaluate and manage third-party vendors and SaaS/cloud-based clinical systems for compliance with data integrity and cybersecurity requirements. Drive continuous improvement of validation methodologies, templates, and SOPs. Support internal and external audits/inspections by providing documentation and demonstrating validation processes. Ensure system access, security, backup, and archival procedures meet both regulatory and company policies. Provide project management support for clinical system implementations, upgrades, ensuring timelines & compliance goals are met and manage multiple projects at the same time. Monitor emerging regulations, technology trends, and industry best practices for relevance to clinical systems validation.Who You Are:You have a Bachelors degree in Computer Science or related field along with 7 + of minimum years of experience in IT/Clinical Systems Validation in Biotech/Pharma Industry.You are or you also have: Solid understanding of data lake technologies, data pipelines construction, and data analysis software particularly in developing integrations between clinical systems and writing data pipeline codes to extract data from source systems. Strong understanding of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5. Hands-on experience with clinical systems validations. Proven ability to manage multiple projects and priorities in a regulated environment. Excellent communication, leadership, and stakeholder management skillsNice to have (but not required): Relevant certifications (e.g., GAMP, CSV-related trainings). Experience working in a biotech startup or high-growth clinical-stage company. * Familiarity with computer system assurance (CSA) principles.Where You'll WorkThis is a hybrid role based out of our Bridgewater NJ HQ office. You'll have the option to work remotely most of the time, with in-person collaboration when it matters mostTravel RequirementsThis role requires occasional [domestic/international/global] travel (approximately 10%)#LI-EG1#HybridPay Range:$133,000.00-173,000.00 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 t

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