Responsible for oversight of suppliers performing archival services in the US thorough SME support for external audits at suppliers providing services for Document Management Responsible for Records Information Management oversight and guidance for GMP/GDP records Manages activities for the system administration of the MasterControl System within Tech Ops Quality, including oversight of User access requests, report management, process and metadata change requests, general customer support, and escalation of issues to IT Responsible for integrating the GMP/GDP documentation systems Oversight and business process owner of GMP/GDP Document Hierarchy, Periodic Review, user book management, Document Processing, including but not limited to Controlled and Managed Documents Responsible for inspection readiness and inspection support of the Tech Ops Quality Manual and Global Quality Standards processesģ0% Document Management Business Process Owner Responsible for integrating acquisitions into the global quality standards systems Provide technical writing support to policy improvement and integration Report status and metrics of QMS Policy implementation status and risks regularly Responsible for establishing Global Quality Standards, maintaining QMS Policy files including reference to regulations, leading gap analysis and implementation planning Responsible for Tech Ops Quality Manual and Global Quality Standards lifecycle Responsible for monitoring system performance through monthly metrics and establishing plans to address trends as neededģ0% Tech Ops Quality Manual and Global Quality Standards Business Process Owner ![]() Identifies, develops, and drive continuous improvement opportunities ![]() Inspire others through a shared vision and purposeĪccountable for team owned quality system records and adherence to established timelines Manages the organization and works with the business to evaluate and provide upcoming resource needsĮstablish and cascade operational objectives as well as personnel development objectives to team membersĬreate and support an environment for Learning and DevelopmentĬreate a motivating environment as a Leader and ensure that the team has the resources they need to be effective. 40% Leader of the Document Management and Global Quality Standards Team
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