Sr. Manager, Computer Systems Validation

Role Summary

Sr Manager, CSV on the Computer System Validations IT team. Based in San Diego, reporting to the Director, CSV you’ll engage on CSV projects as a key team member and provide guidance to ensure computerized systems are deployed following lifecycle management and remain in a validated state per SOPs, regulatory and security requirements.

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
• Participate in on-site Change Control CAB meetings as the CSV lead

Qualifications

• Required: Bachelor’s Degree with 7+ years’ hands-on experience in a validation role with responsibility for computer systems (LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems)

• Preferred: 5+ years’ experience developing and managing project budgets and forecasts
• Preferred: Experience supporting audits or regulatory inspections
• Preferred: Experience with Veeva QualityDocs /QMS and understanding of document management principles
• Preferred: Solid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, GMPs, Data Integrity
• Preferred: Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts
• Preferred: Strong technical writing skills for authoring, reviewing and approving validation plans, requirements, testing documents and summary reports
• Preferred: Familiarity with cloud-based systems and SaaS validation
• Preferred: Experience managing oversight of multiple enterprise projects and processes at one time
• Preferred: Experience in evaluating and validating AI solutions in regulated uses
• Preferred: Strong customer service skills for internal and external customers
• Preferred: Ability to multi-task and prioritize efforts effectively

Education

• Bachelor’s Degree

Skills

• Risk-based validation strategy development
• CSV lifecycle management
• Regulatory and quality systems knowledge (FDA/EU, 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Data Integrity)
• Technical writing and documentation (Validation Plans, Summary Reports, protocols)
• Project management and multi-project oversight
• Training and coaching of GxP system owners
• Vendor management for outsourced validation services
• Experience with Veeva QMS/QualityDocs and cloud/SaaS validation