Global Process Owner, QMS - Document and Change Controls

Requisition ID:  31703  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

As a global process owner, this role provides Quality Management System (QMS) leadership within Terumo Blood and Cell Technologies (BCT) to monitor, maintain and continuously improve processes and supporting technology with respect to Quality Management System (QMS) Elements. This is a key leadership role responsible for communicating and contributing to the development of Terumo BCT’s standardized QMS best practices. This role involves developing and implementing strategies to ensure compliance with regulatory requirements, maintaining integrity, and managing change effectively across the organization.

 

ESSENTIAL DUTIES

• Serves as the global process owner and a subject matter of expert for global regulations, document, and change controls within the QMS area of expertise.
• Spearheads the global process consistent with regulatory and industry best demonstrated practices.
• Strategically plan and set the stage for future improvements within the QMS.
• Develops, implements, and continuously improves standardized processes for QMS document creation, approval, distribution, and change control.
• Ensures adherence to relevant regulatory standards and industry best practices.
• Oversees the creation, review, approval, and maintenance of all organizational documents, including policies, procedures, specifications, and work instructions.
• Implements a robust document control system to ensure version control, accessibility, and traceability of QMS documents.
• Develops and implement change control procedures to manage changes to documents, processes, and systems.
• Facilitates the review and approval of change requests, ensuring thorough impact assessments.
• Collaborates with regulatory affairs function to stay informed about changes in regulations and updates processes accordingly.
• Collaborates with cross-functional teams to understand and document needs across various departments and regions.
• Understands change management and drives changes to align with best demonstrated practices.
• Communicates effectively with stakeholders to be able to influence and create a solid understanding of the QMS process.
• Establishes key performance indicators (KPIs) to measure the effectiveness of the quality system element.
• Develops process workflow and procedure improvements to deploy, teach and coach teams across the globe.
• Develop and maintain training material to ensure compliance of the QMS Element training program.
• Responsible for communication and coordination with business functions, site process owners and site leadership for implementation of process and applicable technology changes.
• Effectively manages, resolves and/or escalates QMS-related implementation and/or interpretation issues in a timely fashion for quick resolution.
• Effectively works with all global process owners to ensure a seamless QMS implementation, interpretation and understanding by the Terumo BCT organization.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

• Bachelor's degree in a relevant engineering or scientific field required.

 

Experience

• Minimum 10 years of experience in Quality, Regulatory Affairs, Manufacturing or Engineering within regulated industry (medical device or pharmaceutical).
• Knowledge and experience interpreting and applying global regulations and standards for QMS (FDA, ISO, EU MDR and/or quality requirements associated with developing medical devices and combination products).
• Demonstrated experience working with, influencing and/or leading global teams required.
• Experience working with electronic document management systems required.
• Experience working in a manufacturing environment is highly preferred.
• Knowledge and experience working within a Quality Management System, integration of QMS elements and expectations of the organization to