Global QMS Specialist

Requisition ID:  33316  

 

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. For Terumo, for Everyone, Everywhere.

 

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. Advancing healthcare with heart.

 

 

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. Join us and help shape wherever we go next. You create your future and ours.

JOB TITLE:  Global Quality Management Systems (QMS) Specialist – Management Controls and QAD Compliance Program

 

JOB SUMMARY

Under minimal supervision, provides quality support for the business by assisting management in complying with global regulatory and Terumo Corporate (QAD) specific requirements.  This position is responsible for managing and exectuting quality system projects across BCT and ensuring compliance with internal and external quality standards across global operations.

 

ESSENTIAL DUTIES

• Works closely with cross-functional teams to ensure consistency in quality management processes, drive continuous improvement, and support global regulatory compliance efforts
• Collaborates with global teams to drive standardization of procedures and policies across sites
• Support global regulatory inspections and audits (external and internal) as requested
• Assist with the creation and revision of QMS documents (includes but not limited to Policies, Standard Operating Procedures, Work Instructions) in accordance with internal requirements and industry best practices
• Act as the liaison between TBCT Global Quality in the US and the corporate Quality Assurance Department (QAD).
• Is the primary project manager for TBCT global quality projects and coordination

Management Controls and QAD Compliance Specific Duties:

• Provide support for the inspection readiness program, including remediation project management, project communication, and executive reporting.
• Works closely with Data Analytics to drive improvements for global quality metrics reporting.
• Manage the portfolio of global quality projects to ensure delivery of organizational objectives, QMS enhancements, and QAD specific projects.
• Develop, implement, maintain and execute Global Quality Plans.
• Maintains Management Control process documents and procedures.
• Manage the execution of Global Quality Management Review logistics and documentation.
• Support Terumo Corp QMS and Shoki-Ryudo Assessments, including process improvements and training initiatives.
• Maintains and owns the Global Management Responsibility List (including changes to PRRC [person responsible for regulatory compliance} quality appointment letters) and initiate changes when necessary by following the internal change control process.
• Serves as a liaison between Terumo Corporate Quality and TBCT Quality. Shares information related to quarterly reports from Corpoarte Quality office (CQO), upcoming regulatory changes and performance reports, and ad-hoc requests.  

MINIMUM QUALIFICATION REQUIREMENTS