Quality CSV SME

JOB DESCRIPTION Our client is a small Biotech research company. They are currently seeking a Quality CSV SME to come on-site 3 days a week in South San Fran. This role is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will share strategic responsibility for the QA CSV function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.

The Role:
Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will share strategic responsibility for the QA CSV function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.

Key Responsibilities:
Implement CSV Strategies: Assist in the execution of GxP computer system validation lifecycle and QA-CSV strategies.
Resource Management: Lead internal and contract resources to ensure effective CSV support for business needs.
Risk Assessment: Collaborate with functional teams to manage risk assessments and develop mitigation plans.
Documentation Oversight: Contribute to the review and approval of CSV documentation, including specifications and validation protocols.
Audit Participation: Engage in vendor assessments and lead routine and complex audits of internal processes and partners.
Compliance Guidance: Provide CSV compliance support to QA and other GxP functions, identifying issues and facilitating continuous improvement.
Inspection Readiness: Prepare for regulatory inspections and assist with responses to findings.
Policy Development: Update and create relevant CSV-related policies, procedures, and templates.
Process Improvement: Identify opportunities for enhancements based on industry best practices and regulatory requirements.


Required Skillset
Biopharmaceutical Experience
CSV Expertise
Tracelink and RIM (Strong Knowledge)
GxP Systems Experience
Strong Communication Skills