Insmed Incorporated · 1 day ago
Sr. Manager, Computer Systems Validation
San Diego, CA
Full-time
Onsite
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, CSV will provide strategic leadership on computer system validations, ensuring that computerized systems are deployed and maintained in a validated state according to regulatory requirements.
BiotechnologyMedicalPharmaceutical
Responsibilities
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
Coordinate and lead validation activities with internal stakeholders and project team members
Author CSV Documents (Validation Plans and Summary Reports)
Ensure training requirements are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.)
Provide real-time oversight and support during test execution
Review executed protocols and provide test protocol deviation assessment and resolution guidance
Train, coach, and mentor GxP system owners
Provide CSV program trainings, lunch and learns and guidance to new stakeholders as well as refresher trainings for existing stakeholders and project teams
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 participate in on site Change Control CAB meetings as the CSV lead
Qualification
Required
Bachelor's Degree
7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems
5+ years' experience developing and managing projects budgets and forecasts
Experience supporting audits or regulatory inspections
Experience with Veeva QualityDocs /QMS and understanding of document management principles
Solid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, GMPs, 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
Experience managing oversight of multiple enterprise projects and processes at one time
Strong customer service skills for internal and external customers
Ability to multi-task and prioritize efforts effectively
Preferred
Experience in evaluating and validating AI solutions in regulated uses
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
2026-01-09
2026-01-09
Company data provided by crunchbase