Senior Manager, Supplier Quality; CMO​/OEM

Requisition : 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…