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CSV Associate Director
2 months ago
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.
