Quality Management System (QMS) Specialist

Role Summary

We’re looking for a Quality Management System (QMS) Specialist on the Analytical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Compliance Manager, Analytical Services, you’ll be essential to maintaining the integrity, accuracy, and compliance of all documentation within the Technical Operations department. You will be responsible for managing the Quality Management System (QMS) for the entire Technical Operations department. This is a hybrid role, out of our Bridgewater, NJ office.

Responsibilities

• Manage processes and facilitate accurate, timely, and effective completion of quality documents in Insmed‚Äôs Veeva Quality Management System.
• Generate reports and develop key metrics on documentation status and compliance using the Veeva Quality Management System to ensure alignment with regulatory and internal quality standards.
• Work closely with Quality Assurance, Regulatory Affairs, Manufacturing, and Analytical teams to support timely documentation updates and approvals.
• Develop and present quality performance insights and recommendations to management based on trend analysis of CAPAs, deviations, and change controls.
• Serve as a key audit contact point by assisting with documentation and report preparation.
• Own and improve the deviation lifecycle management process within Veeva, ensuring efficiency, compliance, and cross-functional accountability.
• Collaborate with various groups within the Technical Operations department to ensure timely completion of Veeva documents such as Deviations, Change Controls, and CAPAs.
• Lead the implementation of document management processes including evaluation of system workflows, SOP revisions, and stakeholder alignment.
• Ensure all documents meet established standards for accuracy, consistency, compliance, and formatting, while monitoring and managing workflows to guarantee tasks and approvals are completed efficiently and on schedule.

Qualifications

• Required: A Bachelor's degree and 2+ years of experience on a document control team using a quality management system, with preference to Veeva.

Skills

• Understanding of pharmaceutical processes and documentation.
• Proficiency with Veeva or similar electronic document management systems.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication abilities.
• Knowledge of GMP and regulatory requirements.
• High interpersonal skills with the ability to work with cross-functional teams.

Education

• Bachelor‚Äôs degree required.