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
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