Senior Manager, Supplier Quality (CMO/OEM)

Terumo BCT, Inc. • Denver, CO

1d • Hybrid

About The Position

Terumo Blood and Cell Technologies is a global company with over 8,000 associates, dedicated to making medical devices and related products for collecting, separating, manufacturing, and processing blood and cell components. The company emphasizes innovation, patient impact, and a strong culture. As the Senior Manager, Supplier Quality (Contract Manufacturing), the role involves leading and managing the External Manufacturing SQE team. This includes daily management, maintenance, and monitoring of team activities, and collaborating with Suppliers, Product Development, Procurement, and Quality to ensure compliant materials. Key responsibilities also encompass overseeing a large portfolio of CMO and distributed product suppliers, implementing quality improvement strategies, and aligning global supplier management requirements. The position requires collaborative development of objectives, plans, and global strategies to achieve business goals.

Requirements

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Minimum 10 years’ experience and five (5) of which have been in a leadership capacity.
• Requires experience with program and project management methods, budgeting, and resource planning.
• 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.

Nice To Haves

• Bachelor of Science degree Mechanical, Industrial, or Biomedical Engineering preferred, or may have a Master of Science degree, in Engineering.

Responsibilities

• 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.

Benefits

• competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs
• multiple group medical, dental and vision plans
• a robust wellness program
• life insurance and disability coverages
• a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more
• 401(k) plan with a matching contribution
• vacation and sick time programs for associates

What This Job Offers

• Job Type: Full-time
• Career Level: Senior