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 from leading workplace and culture organizations, including Science's Top Employers, Great Place To Work® in the U.S., and Fortune's Best Workplaces in BioPharma.
For patients, for each other, and for the future of science, we’re in. Are you?
About the Role:
We’re looking for a Quality Management System Specialist on the Quality Control to help us expand what’s possible for patients with serious diseases. Reporting to the Compliance Manager, Analytical Services, you’ll be the primary steward of quality documentation within the Veeva Quality Management System, supporting biopharmaceutical manufacturing and quality operations. You will manage the end-to-end lifecycle of quality document entry in Veeva, ensuring proper assignment of reviewers, coordinating timely approvals, and maintaining compliance with applicable procedures and regulatory requirements.
What You'll Do:
In this role, you’ll have the opportunity to be responsible for managing expectations and due dates, resolving system and process obstacles, and collaborating cross-functionally across Manufacturing, Analytical, Process Development, and Quality functions. You’ll also:
Document Management & Veeva QMS Operations:
Manage and facilitate accurate, timely, and compliant completion of quality documents within Insmed Veeva QMS, applying applicable document restrictions and access controls as required.
Execute and oversee the change control lifecycle in Veeva, ensuring adherence to applicable Insmed change control procedures and cross-functional alignment.
Maintain and improve deviation lifecycle management processes for biopharmaceutical manufacturing and testing operations, including coordination of investigation child records, root cause documentation, and CAPA linkages.
Ensure all documents meet established standards for accuracy, consistency, compliance, and formatting, and that Veeva workflows, tasks, and approvals are completed efficiently and on schedule.
Document and track changes in the Veeva Vault Quality system, maintaining proper version control, archival, and traceability for GxP records.
Metrics, Reporting & Trend Analysis:
Generate reports and develop key quality metrics on documentation status and compliance using Veeva, ensuring alignment with applicable regulatory expectations and internal quality standards.
Develop and present quality performance insights and recommendations to Quality leadership based on trend analysis of CAPAs, deviations, and change controls.
Support periodic quality reviews by compiling documentation metrics, closure rates, aging records, and compliance KPIs for presentation to QA management.
Cross-Functional Collaboration:
Work closely with Quality Assurance, Regulatory Affairs, Manufacturing, Supply chain Process Development, and Analytical teams to support timely documentation updates and approvals.
Collaborate with Change Control Committee stakeholders to facilitate change plan updates and site-specific Change Control Committee meetings using applicable templates.
Coordinate with the Quality team to support OOS/OOT investigations per internal Insmed procedure and ensure proper linkage and documentation in Veeva.
Serve as a key audit contact point by assisting with documentation preparation, record retrieval, and report generation for regulatory inspections and internal audits.
Process Improvement & Compliance :
Lead the implementation and continuous improvement of document management processes including evaluation of Veeva system workflows, SOP revisions, and stakeholder alignment for the Quality function.
Ensure compliance with…