Insmed Incorporated · 4 hours ago
Quality Management System (QMS) Specialist
Headquarters, NJ
Full-time
Hybrid
Entry Level
$81K/yr - $103K/yr
2+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. They are seeking a Quality Management System (QMS) Specialist to manage the QMS for the Technical Operations department, ensuring the integrity and compliance of documentation while collaborating with various teams to support quality processes.
BiotechnologyMedicalPharmaceutical
Hiring Manager
Tara (Brown) Grindle
Responsibilities
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 team 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
Work closely with Quality Assurance, Regulatory Affairs, Manufacturing, and Analytical teams to support timely documentation updates and approvals
Lead the implementation of document management processes including evaluation of system workflows, SOP revisions, and stakeholder alignment
Collaborate with various groups within the Technical Operations department to ensure timely completion of Veeva documents such as Deviations, Change Controls and CAPAs
Ensure all documents meet established standards for accuracy, consistency, compliance, and formatting, while also monitoring and managing workflows to guarantee tasks and approvals are completed efficiently and on schedule
Qualification
Required
You have a Bachelor's degree along with 2+ years of experience on a document control team using a quality management system, with preference to Veeva
Preferred
An understanding of pharmaceutical processes and documentation, due to the nature of the documents being managed
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 strong communication and ability to work with cross functional teams
Benefits
Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Will Lewis
Chairman and Chief Executive officer
Walter R. Perkins
Chief Technology Officer
Recent News
2026-01-11
2026-01-11
Company data provided by crunchbase