Associate Director, Quality Systems Document Control

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: Reporting to the Senior Director, Global Quality Assurance, the Associate Director, Quality Systems Document Control leads the document control function within the Quality Management System (QMS), ensuring documentation supporting GxP operations meets global regulatory requirements, internal quality standards, and lifecycle management expectations. You will provide leadership and operational oversight of document lifecycle management within the electronic QMS, ensuring processes are controlled, efficient, and inspection ready. You will support the execution of document management strategies by strengthening enterprise-level governance, advancing digital documentation capabilities, and implementing scalable processes that support business growth and operational needs. Partnering with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, and other cross-functional stakeholders, you will ensure documentation practices enable compliant operations and consistent quality standards. What You'll Do: In this role, you’ll have the opportunity to define, supervise and execute global document control strategy aligned with leadership and corporate objectives. You'll also: Drive harmonization of documentation processes across business units and regions. Lead and develop global Document Control initiatives. Identify and implement process improvement projects to drive Quality Management Systems success. Oversee processes within the QMS Document Control System, including process design, monitoring for compliance, and day-to-day operations. Manage and administer the Quality Document Control System. Manage and administer the on-site Document Archive Room. Maintain all activities supporting Document Change Control process, including controlled document lifecycle, change requests, classification, and retention procedures. Monitor, review, and approve Quality Documents. Review all Standard Operating Procedures (SOPs), forms, templates, reports, standard test methods, specifications, and technical documents. Support inspection readiness activities as subject matter expert. Provide support during internal audits, Health Authority audits, and third-party consultant audits. Conduct training of QA and stakeholders in QMS Document Control processes. Who You Are: You have a minimum BS degree in Chemistry, Life Science, or related discipline required as well as 10 years of experience in Quality Systems and/or Document Control within regulated industries (Pharmaceutical, Biotechnology, Medical Device). You are or you have: Demonstrated experience supervising and leading document control operations. Direct experience with Document Control management in pharmaceutical or medical device products. Experience with enterprise electronic document management system (eDMS) implementation and governance. Veeva Vault Quality experience preferred, Full understanding of cGMPs for pharmaceutical products. Familiarity with other GxPs (GCP, GVP, GDP, GLP). Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices. Experience reviewing and approving procedural documents. Core competencies in enterprise-level strategic thinking, executive presence and stakeholder influence, strong analytical and risk-based decision-mak ... (truncated, view full listing at source)