Manager, Quality Systems
Otsuka Pharmaceutical Companies · US
The Manager, Quality Systems is responsible for the design, implementation, maintenance, and continuous improvement of global quality systems that support co...
Job description
The Manager, Quality Systems is responsible for the design, implementation, maintenance, and continuous improvement of global quality systems that support compliance, operational excellence, and risk mitigation across the pharmaceutical product lifecycle. This role is pivotal in ensuring the effectiveness, compliance, and continuous improvement of core quality systems, including Inspections, CAPA, Change Control, Document Management, and Training . The ideal candidate will serve as a strategic partner to IT, enabling digital transformation and governance across the global quality landscape. Key Responsibilities: Lead the development, deployment, and governance of core quality systems (e.g., CAPA, Change Control, Deviation Management, Document Management, Training, Audit Management). Serve as the business process owner for quality system platforms, ensuring alignment with business needs and regulatory expectations. Lead or support global projects related to system implementation, validation, and lifecycle management. Identify and implement process improvements to enhance efficiency, compliance, and user experience across quality systems. Drive process harmonization and standardizati...