Associate Director of IT

Intone Networks

  • Redwood City, CA
  • 4 days ago

    Highlights

    You will oversee Computer Systems Validation (CSV) initiatives while managing multiple concurrent projects in a life sciences environment, balancing strategic governance with hands-on delivery and team leadership. Lead CSV program activities, including validation scope definition, risk assessments, User Requirements Specification (URS) development, and validation documentation management.

    Numbers & Facts

    LocationRedwood City, CA

    Description

    This is a contract position for an Associate Director of IT based in Redwood City, California, with a duration of 6+ months. You will oversee Computer Systems Validation (CSV) initiatives while managing multiple concurrent projects in a life sciences environment, balancing strategic governance with hands-on delivery and team leadership.

    Responsibilities

    • Attend and participate in project maintenance, governance, status update, problem resolution, and timeline meetings
    • Manage 8-9 concurrent projects simultaneously
    • Perform direct contribution work, actively writing and delivering project deliverables
    • Review and approve team work, provide constructive feedback, and ensure problem resolution
    • Conduct bi-weekly one-on-one meetings with team members
    • Lead CSV program activities, including validation scope definition, risk assessments, User Requirements Specification (URS) development, and validation documentation management
    • Validate, implement, and manage ongoing governance for Veeva QMS and QDS systems
    • Lead Change Management platform projects, including process updates and platform qualification
    • Lead SSO platform integration initiatives
    • Develop data migration plans and execute or delegate migration protocols, ensuring compliance, traceability, and verification
    • Own gap assessments, develop remediation plans, and delegate execution to the team
    • Participate in IT leadership meetings and present project updates and risk assessments

    Qualifications

    • Required

    • Previous experience leading a CSV program in a life sciences organization

    • Experience performing CSV activities such as defining validation scope, conducting risk assessments, developing URS, and managing validation documentation

    • Experience validating, using, and managing ongoing governance for Veeva QMS and QDS

    • Experience managing a Change Management platform project, preferably with ServiceNow, including driving process updates and platform qualification

    • Experience managing an SSO platform integration, preferably Okta

    • Experience developing data migration plans and executing or delegating migration protocols with understanding of compliance, traceability, and verification requirements

    • Experience with gap assessments, including owning remediation plan development and team delegation

    • Experience validating Veeva systems such as QDS, CRM, and RIMS

    • Preferred

    • SAS experience

    • Previous experience supporting audits and inspections with regulatory agencies

    • Experience reviewing CSV processes to ensure compliance with regulatory requirements and industry standards including GAMP 5, ITIL ISO, and ICH

    Technology Environment

    • Veeva: Quality Docs, RIM, eTMF, and QMS
    • CTMS and RTSM (Medidata preferred)
    • Okta SSO
    • ServiceNow
    • SAS

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