Global Quality Systems Process Owner - Leader/Lead
Vienna, Austria, Boston, Massachusetts
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Life at Takeda
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Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2019.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
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Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Global Quality Systems Process Owner - Leader/LeadApply Now
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.)
- Business Process Owner (BPO) 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.
Job ID R0014090