Manager, CSV

Insmed Computer Systems Validation Role

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.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role

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. Ensure compliance and operational efficiency of validated systems through participating in release management, change control, periodic reviews, and audit trail reviews.

What You'll Do

Responsibilities will include, but not necessarily limited to the following :

• Develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions
• 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

Position Requirements (Required and / or Preferred Skills, Experience and Education) :

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.

Project lead experience preferred. Strong experience in Clinical Study Systems is required. Experience in evaluating and validating AI solutions in regulated uses is preferred. 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. Ability to multi-task and prioritize efforts effectively. Bachelor's or Master's in Computer Science, Engineering, Life Sciences, or a related field.

Pay Range : $119,000.00-167,267.00 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 pa