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JOB TITLE: ASSOCIATE DIRECTOR OF IT CSV
LOCATION: HYBRID (4 DAYS A WEEK ONSITE) ROLE IN REDWOOD CITY CA*LOCAL TO CA ONLY
JOB DESCRIPTION:
TECHNOLOGY ENVIRONMENT THE CONSULTANT WILL BE WORKING IN:
- Veeva: Quality Docs, RIM, eTMF, & QMS
- CTMS & RTSM Medidata preferred
- Okta SSO
- ServiceNow
- SAS experience
Consultants day-to-day responsibilities:
- Attending project maintenance and governance meetings
- Attending status update meetings, problem resolution meetings, and timeline meetings
- Juggling 8-9 projects
- Direct contribution work actively writing and delivering deliverables
- Revieing and approving work and providing feedback and making sure problems are resolved
- Performing bi-weekly 1on1's
Required Skills:
- Previous experience leading a CSV program in a life sciences organization
- Performing CSV activities, such as: defining validation scope, conducting risk assessments, developing URS, & managing validation documentation
- Validating, using, and managing ongoing governance for Veeva QMS & QDS
- Managing a Change Management platform project, preferably with ServiceNow driving the update of the process and subsequent qualification of SN
- Managing a SSO platform integration, preferably Okta
- Developing data migration plans and executing/delegating the protocols understanding project requirements and best approach for compliance, traceability, & verification, and how to transfer data from source to target systems
- Gap Assessment experience owning and developing remediation plans and delegating to the team
Desired Skills:
- SAS experience
- Previous experience supporting audits and inspections with regulatory agencies
- Prior experience reviewing CSV processes to ensure they meet regulatory requirements and industry standards. These include:
- GAMP 5, ITIL ISO, and ICH
- Prior experience validating Veeva systems such as QDS, CRM, and RIMS required
- Previous experience participating in IT leadership meetings and presenting project updates and risk assessments