CSV Associate Director

Job Title: Computer System Validation SME (Associate Director, Quality Assurance – CSV)

Duration: 3-6 Months to Hire

Location: South San Francisco, CA (On-site 3 days a week)

Type: W2 Contract

Role Overview:

Reporting to the Director of QA Computer System Validation (CSV), the Associate Director will be responsible for overseeing the CSV function. The role will support cross-functional teams to ensure compliance, drive corporate initiatives, and lead the execution of GxP computer system validation projects. As a key member of the quality assurance team, the candidate will independently manage multiple complex projects, provide strategic input, and ensure successful delivery of CSV initiatives.

Required Skillset:

Biopharmaceutical Experience

CSV Expertise

Tracelink and RIM

GxP Systems Experience

Strong Communication Skills.

Key Responsibilities:

Strategic CSV Leadership: Contribute to the execution of GxP computer system validation lifecycles and QA-CSV strategies to meet company goals.

Resource Management: Lead and manage both internal and contract resources to provide effective support for CSV-related business needs.

Risk Management: Collaborate with cross-functional teams to perform risk assessments, identify potential risks, and develop robust mitigation plans.

Documentation and Compliance Oversight: Review and approve critical CSV documentation, including specifications, validation protocols, and reports, ensuring compliance with industry regulations.

Audit Leadership and Participation: Lead routine and complex internal and external audits, including vendor assessments, to evaluate compliance with GxP regulations and CSV requirements.

Compliance and Continuous Improvement: Act as a CSV compliance expert, offering guidance to the quality assurance team and GxP functions. Facilitate continuous improvement through the identification and implementation of best practices and regulatory updates.

Regulatory Inspection Readiness: Prepare and support regulatory inspection activities, including the preparation of responses to inspection findings related to CSV.

Policy and Process Development: Update and develop CSV-related policies, procedures, and templates based on the latest regulatory requirements and industry trends.

Process Optimization: Proactively identify opportunities for process improvements within CSV activities, ensuring alignment with industry best practices.