Sr. Manager, Computer Systems Validation

Role Summary

Sr. Manager, Computer Systems Validation at Insmed. Lead CSV strategy and oversee validation of GxP computerized systems, ensuring ongoing validation and compliance across projects; onsite at the San Diego site.

Responsibilities

• Engage on GxP 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 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.
• Onsite at San Diego site.
• Provide strategic leadership and decision making on CSV strategy.
• 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).
• 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.).
• 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.
• 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 participate in on site Change Control CAB meetings as the CSV lead.

Qualifications

• 7+ years‚Äô hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems.
• 2+ years‚Äô in a managerial role with people/project oversight.
• 5+ years‚Äô experience developing and managing projects budgets and forecasts.
• Experience leading cross-functional teams.
• 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.
• Experience in evaluating and validating AI solutions in regulated uses is preferred.
• Strong customer service skills for internal and external customers.
• Ability to multi-task and prioritize efforts effectively.
• Bachelor's or Master's in Computer Science, Engineering, Life Sciences, or a related field.

Skills

• CSV governance and lifecycle management
• Regulatory compliance (FDA/EU) and GxP knowledge
• Technical writing and documentation
• Project and vendor management
• Risk-based validation planning
• Cloud/SaaS validation
• Change control and audit support
• Cross-functional leadership

Education

• Bachelor's or Master's in Computer Science, Engineering, Life Sciences, or a related field.