Insmed Incorporated · 19 hours ago
Sr Manager, IT Clinical Systems Validation
Headquarters, NJ
Full-time
Hybrid
Senior Level
$133K/yr - $173K/yr
7+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Sr Manager, IT Clinical Systems Validation will lead the planning, execution, and documentation of computer system validation activities for clinical applications, ensuring compliance with regulatory standards and data integrity.
BiotechnologyMedicalPharmaceutical
Responsibilities
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
Qualification
Required
Bachelors degree in Computer Science or related field
7+ years of minimum experience in IT/Clinical Systems Validation in Biotech/Pharma Industry
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
Preferred
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
Benefits
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
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Will Lewis
Chairman and Chief Executive officer
Walter R. Perkins
Chief Technology Officer
Recent News
2026-01-03
Company data provided by crunchbase