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Maintain and own the global quality system and standards strategy roadmap for GxP compliance across all relevant functions and business units.
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Maintain quality standards, policies, and procedures in alignment with global regulatory requirements and industry guidelines.
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Lead the management of quality systems, including document control, change control, deviation management, risk management, and Corrective and Preventive Actions.
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Drive initiatives to enhance operational efficiency, streamline processes, and optimize resource allocation while maintaining the highest quality standards
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Ensure targets are achieved through effective quality performance monitoring, measurement, and analysis and reporting. Identify Quality KPIs, collate KPI data and reporting. Produce KPI metrics to monitor and drive continuous improvement. Collaborate with cross-functional teams to develop and deliver training programs on quality systems, GxP regulations, and compliance requirements.
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Drive vendor management and management of third-party auditors regarding quality system matters and inspections.
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Stay abreast of evolving regulatory guidelines and industry trends to proactively assess and address potential impacts on the organization's quality systems.
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Provide Quality leadership and oversight of the QA Managers, QA Supervisors and QA Specialists to ensure consistent implementation of and compliance to the UPS Healthcare Quality Management System.
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Provide support (when needed) to oversee, review and approve locations Validation, Calibration, and Preventative Maintenance programs to assure consistent implementation of the Marken programs regionally in conjunction with the global validation team.
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Responsible for attending and supporting inspections and visits, performed by the local authorities and certified bodies (e.g. ISO) as required to meet business needs.
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In conjunction with the VP of Healthcare Compliance, Quality \& Regulatory Affairs manage strategic quality initiatives to support business growth.
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Maintain quality service by establishing and enforcing organizational standards
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A member of the Quality Council
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Supporting the VP of Healthcare Compliance, Quality \& Regulatory Affairs to manage the P\&L for Quality
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The primary lead for Corporate Internal Audits
