Associate Director, Quality Systems Document Control

Company: Insmed Incorporated
Location: Bridgewater
Posted on: March 20, 2026

Job Description:

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: Reporting to the Senior Director, Global Quality Assurance, the Associate Director, Quality Systems Document Control leads the document control function within the Quality Management System (QMS), ensuring documentation supporting GxP operations meets global regulatory requirements, internal quality standards, and lifecycle management expectations. You will provide leadership and operational oversight of document lifecycle management within the electronic QMS, ensuring processes are controlled, efficient, and inspection ready. You will support the execution of document management strategies by strengthening enterprise-level governance, advancing digital documentation capabilities, and implementing scalable processes that support business growth and operational needs. Partnering with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, and other cross-functional stakeholders, you will ensure documentation practices enable compliant operations and consistent quality standards. What You'll Do: In this role,you’llhave the opportunity to define, supervise and execute global document control strategy aligned with leadership and corporate objectives. You'll also: Drive harmonization of documentation processes across business units and regions. Lead and develop global Document Control initiatives. Identify and implement process improvement projects to drive Quality Management Systems success. Oversee processes within the QMS Document Control System, including process design, monitoring for compliance, and day-to-day operations. Manage and administer the Quality Document Control System. Manage and administer the on-site Document Archive Room. Maintain all activities supporting Document Change Control process, including controlled document lifecycle, change requests, classification, and retention procedures. Monitor, review, and approve Quality Documents. Review all Standard Operating Procedures (SOPs), forms, templates, reports, standard test methods, specifications, and technical documents. Support inspection readiness activities as subject matter expert. Provide support during internal audits, Health Authority audits, and third-party consultant audits. Conduct training of QA and stakeholders in QMS Document Control processes. Who You Are: You have aminimumBS degree in Chemistry, Life Science, or related discipline required as well as 10 years of experience in Quality Systems and/or Document Control within regulated industries (Pharmaceutical, Biotechnology, Medical Device). You are or you have: Demonstrated experience supervising and leading document control operations. Direct experience with Document Control management in pharmaceutical or medical device products. Experience with enterprise electronic document management system (eDMS) implementation and governance. Veeva Vault Quality experience preferred, Full understanding of cGMPs for pharmaceutical products. Familiarity with other GxPs (GCP, GVP, GDP, GLP). Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices. Experience reviewing and approving procedural documents. Core competencies in enterprise-level strategic thinking, executive presence and stakeholder influence, strong analytical and risk-based decision-making capabilities. Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals and/or ISO 14971 Demonstrate ability to manage projects and variable workloads. WhereYou’llWork This is a hybrid role based out of ourBridgewater, NJoffice.You’llhave theoptiontowork remotely most of the time, with in-person collaborationwhen it matters most. Travel Requirements This role requires occasional[domestic/international/global]travel (approximately[5%–15%]) hybrid LI-EG1 Pay Range: $155,000.00-201,500.00 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. 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 TotalRewards@insmed.com 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. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com ; and/or An alternative selection process by emailing Privacy@insmed.com . Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com .

Keywords: Insmed Incorporated, Lakewood , Associate Director, Quality Systems Document Control, Healthcare , Bridgewater, New Jersey