Associate Director of IT

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

Computer Systems, System Validation, Team Lead/Manager, Biology, Project/Program Management, Multitasking, Environmental Sciences, Problem Solving Skills, Team Player, Validation Documentation, * 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