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Associate Director, Global Quality Operations

Otsuka Pharmaceutical Companies · US

Job Summary The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and optimi...

Job description

Job Summary The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and optimize global quality system processes across a global quality organization. This role is instrumental in ensuring that quality operations are efficient, compliant, and aligned with strategic business goals. Job Description: Operational Excellence: - Lead continuous improvement initiatives across global quality to enhance efficiency, effectiveness, and compliance. - Identify and implement best practices, metrics, and tools to drive performance and accountability. - Facilitate cross-functional collaboration to streamline and optimize end-to-end workflows, as well as enhance overall operational alignment. - Ensure effective change management strategies are applied to drive successful implementation and adoption of operational initiatives. Risk Management: - Develop and maintain a proactive quality risk management framework aligned with ICH Q9 principles. - Conduct risk assessments for quality processes, systems, and operations, and support mitigation planning. - Monitor and report on key risk indicators and escalate critical risks to...