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The Associate Director, Computer Systems Validation (CSV), Equipment Commissioning & Qualification (ECQ) supports the activities and personnel associated with design, development, delivery, validation, maintenance and support of GMP computerized systems at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers. The individual supports multiple projects and ongoing work activities of low to moderate complexity to ensure compliance to regulatory requirements. The individual directly supervises contract and/or full-time staff to facilitate the completion of departmental deliverables. The incumbent is responsible to author, maintain and manage the System Development Life Cycle for Qualification of Equipment and Validation of Systems. The incumbent will provide direct leadership and oversight over the Compliance Team responsible for the Historical Performance Review.
