Senior Manager, Supplier Quality (CMO/OEM)

Requisition ID:  34079  

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.

Senior Manager, Supplier Quality (Contract Manufacturing) will focus on the management of the external manufacturing SQE team with function including the daily management, maintenance, and monitoring of the relevant activities of all team members. This involves leading an engineering team that works collaboratively with suppliers, product development, procurement, and quality to ensure compliant materials. Responsibilities include oversight of extensive portfolio of Contract Manufacturing Organization (CMO) and distributed product suppliers, implementation of quality improvement strategies, and alignment of global supplier management requirements. Works collaboratively developing objectives, plans, and global strategies to ensure effective achievement of business goals and objectives. 

ESSENTIAL DUTIES

• Demonstrates broad management experience across and recognized as an expert within and outside of the Company with fully developed leadership skills and a deep understanding of a broad issues vital to the company working with multiple functions that are unrelated.
• Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Participates in the short and long term planning process that establishes technical objectives for a business unit project or functional engineering group.
• Utilizes technical, managerial expertise and creativity to evaluate proposed solutions, adaptations, and modifications to projects and products used globally.
• Identifies opportunities and initiates prioritization in addition to implementation.
• Completes regular resourcing and budgeting pertaining to a team. Accountable for long range planning.
• Implements and understands FDA or global regulatory requirements as necessary, in partnership with cross-functional colleagues.
• Ensures compliance with company Quality System regulations and safe working practices.

MINIMUM QUALIFICATION REQUIREMENTS
Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science degree or may have a Master of Science degree, in Engineering, preferred.

Experience

• Minimum 10 years’ experience, five (5) of which have been in a supervisory capacity.
• Requires experience with program and project management methods, budgeting, and resource planning.

Skills

• Demonstrated ability to lead an engineering bringing deep domain expertise to diverse projects.
• Ability to manage geographically-diverse teams and collaborators, as well as work effectively and efficiently with CMOs and / or contract design firms.
• Skilled ability to balance commercial and development needs to accomplish global business area goals.
• Advanced understanding and application of Design Controls and Quality Management Systems to product development and lifecycle management.
• Broad management experience across and recognized as an expert within and outside of the Company with fully developed leadership skills and a deep understanding of a broad issues vital to the company working with multiple functions that are unrelated.
• Work collaboratively with business segment, regional and functional product development leaders to establish and nurture long term goals for the team, department, and function.
• Broad theoretical knowledge of management, quality, global regulatory standards, and or manufacturing.
• Requires working knowledge of the business's products and therapeutic uses.
• Effective leadership, managerial, and strategic planning and global skills.
• Exceptional demonstrated expertise in planning, budgeting, associate development, and project management directed toward achievement of annual, long term, and strategic business plans and goals.
• Requires an exceptional understanding of technology and methods applicable to the area and the ability to determine appropriate application. Examples may include CAD design and packages, FEA packages, industrial design and user-centered design, principles and practices of machining and rapid prototyping.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and in writing.

-Or-

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

Certificates, Licenses, Registrations
Passport may be required.

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

TRAVEL
Requires domestic and international travel based on business needs.

PHYSICAL REQUIREMENTS

• General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
• 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:  $160,400.00 to $200,600.00  -  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:  20.0%

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.