Associate Director, QA CSV (Radnor, PA)

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Associate Director, QA Computer System Validation

Responsibilities:

• Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV / CSA strategies
• Actively support the CSV / CSA functional strategies and multi-year roadmap, and actively take part in developing parts of the strategy
• Lead internal and contract resources to manage CSV / CSA activities and ensure adequate support to meet business needs
• Participate in global/enterprise wide GxP-CSV / CSA projects and contribute to computer system validation working groups and strategies
• Manage risk assessments with functional teams to assess system risks and develop mitigations
• Provide input to CSV / CSA documentation and oversee the execution of qualification/validation activities
• Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports)
• Participate in vendor assessments and/or audits. Manage and/or lead CSV / CSA routine and complex audits including but not limited to internal processes, vendors and business partners
• Interact regularly with members of QA and other GXP functions to provide expert CSV / CSA compliance guidance, identify issues and support continuous improvement
• Perform CSV / CSA inspection readiness preparations and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable
• Update and/or create computer system related policies, procedures, templates, forms, etc.
• Provide guidance and expertise on the validation approach in compliance with regulations to project teams as necessary
• Lead new system selection processes including requirement gathering, RFP development, and software vendor selection
• Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations
• Identify and implement process improvements against industry best practices, regulatory guidelines and requirements
• Review and approve computer system SOPs, change controls, deviations, and CAPAs

Basic Requirements:

• 10+ years of experience supporting computerized systems within regulated pharmaceutical, biotechnology, medical device, or life sciences environments.
• Pharmaceutical Industry Experience Required
• Strong GCP/GMP knowledge
• Clinical Systems: Medidata Rave, CTMS, eTMF, SaaS platforms
• TraceLink Experience Required
• Trackwise Experience Required

** This role is a 12-month contract-to-hire opportunity requiring 3 days per week on-site**

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