Quality Management System 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 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 21 CFR Parts 210, 211, and applicable regulatory guidance, as well as Insmed’s Principal SOP for Veeva Quality Docs.

• Support the maintenance of document control procedures and archival processes, including restricted and non-restricted documentation in Veeva.

Who You Are:

Basic Qualifications

You meet one of the following minimum education and experience requirements:

• Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field; OR
• High School Diploma/GED and 4 years of experience in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.

You are or you also have:

• Hands-on experience with Veeva Vault Quality Docs or equivalent electronic document management systems (EDMS).

• 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 (e.g., batch records, sampling plans, specifications).

• Strong attention to detail and organizational skills; ability to manage multiple quality records simultaneously across competing priorities.

• Excellent written and verbal communication abilities, with demonstrated experience working cross-functionally in a regulated biotech or pharma environment.

• High interpersonal skills with the ability to collaborate effectively with cross-functional teams including Manufacturing, Regulatory, Process Development, and Quality leadership.

• Experience with Veeva Vault GxP Training module or equivalent Learning Management Systems (LMS) for tracking training compliance.

• Demonstrated ability to develop and present quality metrics and trend analysis dashboards to QA leadership.

Preferred Qualifications

In addition to meeting the basic qualifications above, you will also possess some or all of the following:  

• Experience in Gene Therapy (GT) and/or Large Molecule biologic manufacturing and quality operations is strongly preferred.

• Familiarity with GT-specific Veeva QMS workflows, forms, and document restriction frameworks.

• Knowledge of regulatory requirements specific to gene therapy products, including applicable FDA guidance documents and ICH guidelines for biologics and advanced therapy medicinal products (ATMPs).

• Experience supporting OOS/OOT investigations and deviation management within a GT or Large Molecule manufacturing context.

• Prior exposure to GT or Large Molecule Change Control Committee processes and documentation standards.

Where You’ll Work

This is a hybrid role based out of our Bridgewater, NJ office. You’ll work remotely most of the time, with in-person collaboration when it matters most.

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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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [email protected].