Quality Management System (QMS) Specialist

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:
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.

What You'll Do:

• In this role, you'll have the opportunity to manage processes and facilitate accurate, timely, and effective completion of quality documents in Insmed's Veeva Quality Management System. You'll also:

• 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.

Who You Are:

• You have a Bachelor's degree along with 2+ years of experience o n a document control team using a quality management system, with preference to Veeva.

You are or also have:

• 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.

#LI-TB1

Pay Range:
$81,000.00-103,000.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.