Quality Management System Specialist

Insmed Incorporated•NJ Corporate Headquarters, NJ

3d•$81,000 - $103,000•Hybrid

About The Position

Insmed is seeking a Quality Management System Specialist within Quality Control to steward quality documentation in the Veeva Quality Management System. Reporting to the Compliance Manager, Analytical Services, the specialist manages the end-to-end lifecycle of quality document entry, including reviewer assignment, approvals, and compliance with procedures and regulatory requirements. The role supports biopharmaceutical manufacturing and quality operations, manages due dates and obstacles, and collaborates across Manufacturing, Analytical, Process Development, and Quality functions. The specialist manages document control, change controls, deviations, CAPA linkages, quality metrics, trend analysis, and records for audits and regulatory inspections. The position also leads improvements to document management processes and supports compliance with applicable GMP regulations, guidance, and Insmed procedures. This is a hybrid position based out of Insmed’s Bridgewater, New Jersey office, with remote work most of the time and in-person collaboration as needed. The listed annual pay range is $81,000–$103,000.

Requirements

Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field; or a high school diploma/GED and four years of experience in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
Hands-on experience with Veeva Vault Quality Docs or an equivalent electronic document management system.
Working knowledge of GMP and regulatory requirements applicable to biopharmaceutical products, including relevant regulatory expectations and applicable ICH guidelines.
Understanding of biopharmaceutical manufacturing processes and quality documentation requirements, such as batch records, sampling plans, and specifications.
Strong attention to detail and organizational skills, with the ability to manage multiple quality records across competing priorities.
Excellent written and verbal communication skills and demonstrated cross-functional experience in a regulated biotech or pharmaceutical environment.
Strong interpersonal skills and ability to collaborate with Manufacturing, Regulatory, Process Development, and Quality leadership.
Experience with Veeva Vault GxP Training or an equivalent learning management system for tracking training compliance.
Ability to develop and present quality metrics and trend analysis dashboards to QA leadership.

Nice To Haves

Experience in gene therapy and/or large-molecule biologic manufacturing and quality operations.
Familiarity with gene-therapy-specific Veeva QMS workflows, forms, and document restriction frameworks.
Knowledge of regulatory requirements specific to gene therapy products, including applicable FDA guidance and ICH guidelines for biologics and advanced therapy medicinal products.
Experience supporting OOS/OOT investigations and deviation management in a gene therapy or large-molecule manufacturing context.
Exposure to gene therapy or large-molecule Change Control Committee processes and documentation standards.

Responsibilities

Manage accurate, timely, and compliant completion of quality documents in Insmed’s Veeva QMS, including document restrictions and access controls.
Execute and oversee the change control lifecycle in Veeva in accordance with Insmed procedures and cross-functional requirements.
Maintain and improve deviation lifecycle management, including investigation child records, root-cause documentation, and CAPA linkages.
Ensure documents meet standards for accuracy, consistency, compliance, and formatting, and that Veeva workflows, tasks, and approvals are completed efficiently and on schedule.
Track changes in Veeva Vault Quality and maintain version control, archival, and traceability for GxP records.
Generate reports and quality metrics on documentation status and compliance.
Analyze trends in CAPAs, deviations, and change controls and present quality performance insights and recommendations to Quality leadership.
Compile documentation metrics, closure rates, aging records, and compliance KPIs for periodic quality reviews and presentation to QA management.
Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, Process Development, and Analytical teams on documentation updates and approvals.
Facilitate change plan updates and site-specific Change Control Committee meetings using applicable templates.
Coordinate with the Quality team on OOS/OOT investigations and ensure appropriate linkage and documentation in Veeva.
Support regulatory inspections and internal audits through documentation preparation, record retrieval, and report generation.
Lead implementation and continuous improvement of document management processes, including Veeva workflow evaluation, SOP revisions, and stakeholder alignment.
Support document control procedures and archival processes for restricted and non-restricted Veeva documentation.
Comply with 21 CFR Parts 210 and 211, applicable regulatory guidance, and Insmed’s Principal SOP for Veeva Quality Docs.

Benefits

Comprehensive medical, dental, and vision coverage
Mental health support
Annual wellbeing reimbursement
Employee Assistance Program
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with competitive company match
Annual equity awards
Employee Stock Purchase Plan
Company-paid life and disability insurance
Company Learning Institute, LinkedIn Learning, skill-building workshops, leadership programs, mentorship, and networking opportunities
Employee resource groups, service and recognition programs, and opportunities to connect, volunteer, and give back