GxP Clinical Systems IT Manager

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 GxP Clinical Systems IT Owner in the IT team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Clinical Systems & Business Intelligence, you’ll be responsible for ensuring that clinical IT systems are implemented, validated and maintained in compliance with FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other applicable regulatory guidelines.

What You'll Do:

In this role, you’ll have the opportunity to work cross-functionally with Quality, Clinical business teams, Regulatory, and external vendors to ensure validated systems meet business and compliance requirements throughout their lifecycle. You’ll also:

• Lead the planning, execution, and documentation of computer system validation (CSV) activities for clinical applications.
• Collaborate with business owners, QA, and CSV teams to ensure validation deliverables meet GxP and regulatory compliance standards.
• Author and/or review validation documentation including Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ), etc.
• Create change controls, periodic reviews, and revalidation efforts throughout the system lifecycle.
• Evaluate and manage third-party vendors and SaaS/cloud-based clinical systems for compliance with data integrity and cybersecurity requirements.
• Drive continuous improvement of validation methodologies, templates, and SOPs.
• Support internal and external audits/inspections by providing documentation and demonstrating validation processes.
• Ensure system access, security, backup, and archival procedures meet both regulatory and company policies.
• Provide project management support for clinical system implementations, upgrades, ensuring timelines & compliance goals are met and manage multiple projects at the same time.
• Monitor emerging regulations, technology trends, and industry best practices for relevance to clinical systems validation.

Who You Are:

You have a Bachelors degree in Computer Science or related field along with 4 of minimum years of experience in IT/Clinical Systems Validation in Biotech/Pharma Industry.

You are or you also have:

• Strong understanding of GxP regulations
  , 21 CFR Part 11
  , Annex 11
  , and GAMP 5.
• Hands-on experience with clinical systems validations.
• Proven ability to manage multiple projects and priorities in a regulated environment.
• Excellent communication, leadership, and stakeholder management skills

Nice to have (but not required):

• Relevant certifications (e.g., GAMP, CSV-related trainings).
• Experience working in a biotech startup or high-growth clinical-stage company
  .
• Familiarity with computer system assurance (CSA) principles.

Pay Range:

$133, ,000.00 Annual

Life at Insmed

Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below.

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…