Leader, Global Quality Factory Support

Requisition ID:  32740  

 

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.

 

This role is responsible for global production quality that oversees the development at all manufacturing sites including the processes, standards, and teams accountable to deliver best-in-class product quality that meets customer expectations and assures the safety of patients. In cooperation with the global manufacturing leader, this role creates a culture of quality and continuous improvement in everything we do, putting patient safety at the center of our daily focus.

 

As the global quality factory support leader and subject matter expert for Global Quality Assurance, the incumbent works closely with cross-functional quality and organizational leaders, drawing out globally diverse thinking and idea generation, integrating best-in-class quality, design and manufacturability perspectives along with front-line customer understanding to drive continuous state of audit readiness as well as quality improvement at each site.  Provides inspirational guidance, bringing out the best in associates by instilling a bias for customer impact, data-driven results, commitment to excellence, and a collaborative, high-performing culture focused on continuous improvement and compliance.     

 

Develops and maintains exceptional internal and external relationships with stakeholders and regulatory agencies, regularly monitoring the external landscape as it relates to the Company’s long-term business objectives.  Ensures all quality activities are in accordance with applicable laws, rules and regulations of the intended markets meeting the highest quality standards and customer expectations.

 

DUTIES AND RESPONSIBILITIES

Production Quality:

• Ensure factories are “ever-ready” for MOH/FDA inspections by constantly reviewing and addressing gaps.
• Demonstrate growth mindset and support factory operations teams by ensuring product releases in a timely fashion to meet customer service levels.
• Ensure site quality teams deliver in the areas of process improvements, trend monitoring, and correlating leading quality metrics, problem solving approaches, and data analysis.
• Drive responsive communication on product quality issues and resolutions across key stakeholders including supply chain, factories, commercial teams, and our customers.
• Report on and improve metrics related to product quality from all the manufacturing sites.
• Evaluate changes to products ensuring that the manufacturing implications of changes are fully understood.
• Leads Management Review for all factories.

Facilitation and Relations:

• Develop constructive relationships with cross- functional leaders. Clarify and simplify problems and develop bridge-building solutions that improve relationships across all functions and processes in BCT.
• Facilitate the sharing and implementation of quality best practices across the company.
• Work with internal resources to resolve problems of exceptional complexity and sensitivity. May be primary representative of quality group on projects or management teams.
• Understand customer issues and works to resolve problems with product, procedures and policies, driving change where necessary at the factories to resolve these issues.