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.

People Management and Team Development:

• Develop and ensure all associates demonstrate the values and behavior principles of the company. Accountable for continuous development toward actual expectations and associate development
• Ensure effective formal training and development of professional skills and behaviors for team members. Participate and promote team members participation on cross-functional and/or inter- organizational teams. Frequently lead such teams or task groups, especially when the scope is broad and/or the issue complex.
• Direct the development and management of budget for areas of responsibility.
• Recruit, select, train, appraise performance, and administer salaries & bonuses of reporting employees; determines assignments and changes employees’ status in accordance with Terumo BCT policy.

Business Processes:

• Ensure that activities are managed in accordance with Terumo BCT Standards of Business Conduct and appropriate business controls. Establishes and drives aggressive programs to improve the quality and productivity of systems, tools, training processes, and procedures.
• Prioritize and manage resources effectively to optimize the improvement of business processes across Terumo BCT.
• Understand business process issues and works together with business process leadership to resolve problems in the processes, procedures and policies, driving change where necessary. Accountable for operating policy for area of responsibility.
• Develop and effectively manage systems (People, Processes, Software) with a high degree of responsiveness and flexibility to meet the needs of customers and management.
• Influence short and long term business goals. Exert influence on corporate objectives and long-range goals in areas related to QMS and compliance.

Other Responsibilities:

• Manage the development and implementation of business objectives, strategies, processes, tools, and systems to improve quality and productivity, optimize customer satisfaction and return on assets, to meet business needs and ensure business controls. Responsible for internal and external audits and the product release process. May be involved with Group or company councils/ committees working on strategic initiatives and projects.
• Develop and direct implementation of plans for the purpose of achieving multi-functional and cross-functional goals intended to support business objectives through appropriate use of human and technology resources (internal and external).
• Lead problem-solving teams. Ensures subordinate participation on inter/intra organizational teams.

MINIMUM QUALIFICATION REQUIREMENTS

Education & Experience

Bachelor’s degree in an appropriate Engineering or Scientific field, Quality, or a related discipline with a minimum of 12 years’ experience, including 8 years leadership experience in the areas of quality assurance desired in a highly matrixed, global healthcare environment.  Minimum of 5 years’ experience managing complex, geographically diverse teams. 

Capabilities

• Demonstrated skills in leadership and development of people and teams. Capability to build and maintain effective working relationships across functions and organizations and levels.
• Demonstrated effectiveness with interpersonal skills and the ability to interface with Senior Management, internally and externally.
• Demonstrated expertise in planning, budgeting, personnel development, and project management directed toward achievement of annual, long term and strategic business plans and goals.
• Demonstrates a positive, direct, proactive approach to problem solving and impediments, mentors others to understand and model this approach. Constructive and relentless in pursuit of solutions. Motivates others to do the same.
• Understanding of customer needs, product technology, technical support, therapy, use and user market applicable to the area and the ability to determine appropriate actions.
• Requires understanding of quality management techniques and experience in developing quality goals and measures and directing others, including suppliers.
• Thorough understanding of measures of customer satisfaction and experience in their implementation as a tool for continuous improvement.
• Ability to use and teach technology and methods necessary to facilitate Quality System design and continuous improvement across BCT, including process mapping and redesign, project management, metrics selection and monitoring.
• Strong communication skills: Meeting facilitation, verbal and written communication across all levels, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, and project management.
• Ability to contribute at the global / strategic business level.
• Cultural and situational flexibility and adaptability is essential.
• Ability and success to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis and other analytical techniques.
• Demonstrated knowledge and application of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
• Demonstrated leadership and team skills.
• Demonstrated history of willingness to take ownership and accept responsibility for actions and decisions.
• Demonstrated interpersonal skills and the ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Demonstrated problem solving ability – enjoys learning, seeks additional information

-OR-

An equivalent competency level acquired through a variation of these qualifications may be considered.

LOCATION

Lakewood, Colorado - Open to candidates willing to relocate to the area. 

Travel

US and International travel will be required at < 45%.

There will be an occasional requirement to work outside of normal business hours, consistent with other Director-level positions.

PHYSICAL REQUIREMENTS

• Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:  $217,700.00 to $272,100.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  40.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.