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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**