OBJECTIVES/PURPOSE (3-4 bullets)
- The purpose of this role is to provide global leadership and ensure consistent execution of assigned key process owned by Quality (example are but not limited to Deviations, Corrective and Preventive Action (CAPA), Quality Improvement Programs (QIP), Change Control, Documentation and Training and Records Management.
- Process Owner (PO) is accountable for the development, deployment, maintenance, and continuous improvement of assigned processes, including procedures, practices and standardized global training materials
- The Process Owner will ensure that process requirements are effectively deployed in interdependent processes, projects, and/or initiatives.
- This will include serving as key point of contact for assigned processes as well as Program, Project, or Workstream Lead on cross-functional teams. Accountable for contributions to the project delivery for cross-functional project.
ACCOUNTABILITIES (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 - 10 bulleted task statements should be identified).
- Responsible for ownership of assigned global procedure and has the oversight for implementation in close cooperation with system owner.
- Maintain global procedure(s), and training materials in compliance with Global cGMP requirements and Takeda´s Global Quality Standards (GQS).
- Support deployment of global process by close cooperation with functional Quality Compliance and Systems and site execution leads. Provide training, support and coaching as required.
- Support sites and function during regulatory inspections or customer audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
- Drive knowledge sharing via Community of Practice (COP), define operating mechanisms, and communication strategies for COP. Actively participate in other Takeda´s knowledge sharing platforms
- Define process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms. This includes both product quality and process effectiveness aspects.
- Collaborate with other Process Owners and SMEs to drive optimal execution incl. continuous improvement of assigned process across Takeda.
- Collaborate with Computerized System Owners and SMEs on workflow design, provide end-user input drive optimal design of quality systems.