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Director Quality Management Systems

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Date: Apr 18, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  27153  
Annualized Pay Range:  $161,400.00 to $201,700.00 
Target Bonus on Base:  30.0%

 

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.

 

 

Develops strategies to implement and optimize the global Quality Management Systems. Directs the activity of global QMS team members to achieve QMS programs, policies, processes, procedures and controls that enables customer delight, regulatory compliance, and business growth.  Champions quality principles throughout the enterprise by establishing quality systems, capabilities, and mechanisms for monitoring compliance from development through manufacturing. Partners with cross-functional organizational leaders to ensure an effective and compliant quality system and audit readiness.  Oversees the global CAPA program, quality system training, internal and external audit program, including cGMP compliance and regulatory agency inspection readiness.

 

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.  Acts as primary point of contact for audits / inspections (regulatory, customer, notified body) and represents the Company in negotiations with regulatory agencies on quality matters worldwide.

 

DUTIES AND RESPONSIBILITIES

  • Accountable for the development, successful implementation and oversight of Terumo BCT’s global quality management system in accordance with applicable standards and ensuring 100% global audit readiness and consistency.
  • Identifies compliance gaps and develops best practice and process improvements initiatives to ensure  global process/system alignment and timely execution of remediation activities.
  • Champions and supports quality change initiatives through transparency, collaboration, and engagement. Drives a culture of quality, leading through influence and alignment to cross-functional leaders.
  • Oversees internal audit programs to maintain ISO certification and regulatory compliance.
  • Oversees external regulatory compliance audits and relationships with industry groups, regulatory agencies and customers (e.g., FDA, Notified Bodies, Customers, Health Canada and other international regulatory agencies).
  • Ensures complaint investigations and CAPA systems compliance to regulatory requirements.  Contributes subject matter expertise and collaborates with engineering, manufacturing, regulatory affairs, operations and product development to proactively and systematically evaluate, solve and put in place exceptional processes and systems which address and/or prevent quality issues. 
  • Oversees training programs to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance. 
  • Develops systematic approaches to develop best-in-class quality expertise, capabilities, and competencies throughout the organization
  • Actively mentors, coaches and develops leadership capabilities within his/her direct reports and future leaders, instilling a culture of growth, learning and development to accomplish business objectives.  
  • Responsible for creating and tracking the budget including staffing, and timelines in collaboration with other leaders of the QMS team.
  • Communicates on all levels with senior management, including technical, strategic, and business.

 

  

MINIMUM QUALIFICATION REQUIREMENTS

Education & Experience

Bachelor’s degree in an appropriate Engineering or Scientific field, Quality or a related discipline with a minimum of 10+ years’ experience, including 8+ years leadership experience in the areas of quality assurance, global complaint management and post-market surveillance expertise desired in a highly matrixed, global healthcare environment.  Minimum of 5+ years’ experience managing complex, geographically diverse teams. 

 

Capabilities:

  • Successful track record in leading the development and implementation of state-of-the-art global quality management systems/engineering principles for a diverse range of products (hardware, disposables) in medical devices ranging from class 1 to class 3, along with knowledge of pharmaceutical / combination product regulations.
  • Prior success building out an enterprise-wide, robust continuous improvement programs and functions including product complaints, CAPA programs and QMS capabilities which generated substantial year-over-year value in terms of product quality, customer satisfaction, revenue growth, and/or operational effectiveness.
  • Proven leader with a successful track-record of developing high performing cultures and diverse teams across multiple sites, geographies, cultures and regions; empowering and holding accountable direct reports and cross-functional teams for successful implementation and execution of project plans and organizational initiatives.
  • Pragmatic, pressure tested and proven leader, adept in successfully negotiating and responding to audits and inspections, product recalls, and/or critical issues.
  • Respected leader with a proven history of successful interactions with notified bodies and regulatory agencies
  • Proven success in driving innovation and operational performance through product quality, demonstrating extensive understanding of the complex, highly regulated and fiercely competitive landscape across the broader global life sciences and medical device industries.
  • Extensive knowledge of U.S. and international medical device regulations and standards (CFR 820, MDD and ISO 13485) including best practices in Quality System Regulations required.
  • Strong influential leadership with Expert knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources, along with communication skills (verbal/written) to influence at all levels of the organization.
  • Demonstrated ability to manage highly complex budget, investment, and human capital portfolios with the application of quality expertise to achieve or exceed organizational performance objectives.
  • Expertise in leveraging program and project management disciplines, methodologies and practices to accomplish goals, objectives, timelines and milestones.  Prior demonstrated success in leading six sigma, LEAN or other efficiency initiatives highly desirable.   
  • Demonstrated knowledge of professional communications (with CEO / Executive team and with peers and cross-functional teams), problem solving, strategic reasoning, teamwork, change management, business acumen and business ethics.
  • Demonstrates a bias for action and unafraid to tackle complex or difficult challenges.
  • Demonstrates superior tact and organizational savvy; deftly navigating the organizational context and climate to surface and resolve problems and/or crisis appropriately.

-OR-

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

 

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.

  

Additional Physical Requirements

Requires travel based on business needs <25%.

 

 

 

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.


Nearest Major Market: Denver

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