Manager, CSV

Company: Insmed Incorporated
Location: Bridgewater
Posted on: January 3, 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: We’re looking for a Manager, CSV on the Computer System Validations IT team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, CSV you’ll in this role, you will engage on CSV Projects as a key team member. Provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (e.g. SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. What You'll Do: In this role, you’ll have the opportunity to develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions. You’ll also: Coordinate all validation activities with outsourced validation vendor when managing cloud applications. · Manage and provide oversight on multiple projects simultaneously. · Author CSV Documents (Validation Plans and Summary Reports) · Assist/co-author requirements, testing, specification, and other validation project deliverables · Ensure training requirements are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.) · Guide project team members on CSV projects ensuring team members follow laid out CSV plans · Provide real-time oversight and support during test execution and review executed protocols · Provide operational support in maintaining systems in a validated state including Change Control Assessments, Upgrade and Patch assessments, Release assessments. · Manage day-to-day operations of the CSV function including managing CSV system folders in the CSV SharePoint site, managing CSV documents in Veeva, routing documents for review and approval in Veeva etc. · This role will also provide CSV oversight in the IT Change Control processes (both in ServiceNow and the GxP IT CAB process) Who You Are: You have a Bachelor’s Degree along with 5 years’ experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical/Manufacturing systems You are or you also have: Project lead experience preferred. Strong experience in Clinical Study Systems is required. Experience with Veeva QualityDocs /QMS Solid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity. Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts. Strong technical writing skills for authoring, reviewing and approving validation plans, requirements, testing documents and summary reports. Familiarity with cloud-based systems and SaaS validation Strong customer service skills for internal and external customers and comfortable working in cross functional teams Nice to have (but not required): Experience in evaluating and validating AI solutions in regulated uses is preferred. Where You’ll Work This is a hybrid role based out of our Bridgewater HQ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most. LI-JT1 LI-Hybrid Pay Range: $133,000.00-173,000.00 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 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.

Keywords: Insmed Incorporated, Plainfield , Manager, CSV, IT / Software / Systems , Bridgewater, New Jersey