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Senior Manager, QMS Global Operational Controls

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Date: Apr 26, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  27328  

 

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.

 

JOB SUMMARY

Provides Quality Management System leadership within Terumo BCT to monitor, maintain and continuously improve processes and supporting technology to ensure compliance to all applicable regulations for Terumo BCT products with respect to Operational Controls, including, but not limited to P&PC, SCA, NCs and CAPAs. The primary responsibility of the position is to lead the global, cross-functional organization to be compliantly effective and organizationally efficient in the implementation of Global Operational Controls processes and use of applicable technology.

 

ESSENTIAL DUTIES

  • Leads Global Process for Operational Controls, consistent with company, regulatory and professional standards, through monitoring, continuous improvement and implementation of process and applicable supporting technology.
  • Serves as expert for global regulations, standards and processes within Operational Controls area of responsibility with collaboration with Regulatory Affairs on regulatory trends and activity on industry forums, as appropriate.
  • Responsible for communication and coordination with business functions, global QMS teams and Site Leadership for implementation, teaching and coaching of process and applicable technology changes.
  • Effectively manages, resolves and/or escalates QMS-related implementation and/or global interpretation issues in a timely fashion for quick resolution.
  • Delivers purposeful, well-organized presentations on changes, issues, resolutions and forward-thinking vision for Operational Controls processes and associated supporting technology.
  • Effectively works with all Global Process Owners and QMS Governance leader to ensure a seamless Quality Management System implementation, interpretation and understanding by the Terumo BCT organization.
  • Develops and maintains metrics for QMS Operational Controls that support the business and management review needs.
  • Manages scope and schedule for Operational Controls updates and associated training and drives quality, on-time completion for implementation and ongoing changes across the TBCT cross-functional organization.
  • Lead Operational Control work and utilize influence skills at all levels of the organization; coach, mentor and teach peers and reports as well as successfully teaching and influencing leadership teams towards efficient compliance and assisting with functional excellence approaches.
  • Oversees the work of the Global Process Owners.

 

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 in Engineering, preferred.

 

Experience

  • Minimum 8 years experience in Quality, Regulatory Affairs, Manufacturing or Engineering within regulated industry (e.g. medical device, pharmaceutical).
  • Preferred minimum of 5 years Regulatory Compliance/Regulatory Affairs experience involving US FDA Class II or Class III medical devices
  • Knowledge and experience interpreting and applying global regulations and standards for Quality Management System.
  • Demonstrated experience working with, influencing and or leading global teams.
  • Knowledge and experience working within a Quality Management System, demonstrated ability to understand and explain the basics of how the Qaulity Management System works, integration of QMS elements and expectations of the organization to meet QMS requirements.

 

Skills

  • Demonstrated ability to develop and implement compliant, efficient processes.
  • Strong communication skills within cross functional teams, active participation and effective influence skills, mentoring and acceptance of constructive criticism, technical leadership, project management, coordination with cross functional team members and support for subordinates, junior engineers, technicians, and management.
  • Demonstrated ability to learn and apply new technology to business/QMS processes to the level of supporting other members of the organization; ability to explain technology needs to the IT organization for conuous technology improvements
  • Ability to lead a team, with varying perspectives, to quick consensus and support
  • Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
  • Ability and willingness to work on multiple topics to meet business needs
  • Demonstrated ability to effectively lead and manage peers, as needed to implement improvements to QMS processes and applicable tools
  • Demonstrated ability to develop and maintain the overall project vision and strategy while managing the tactical details and activities.
  • Ability to manage conflicts; to read situations quickly, to lead by influence, leverage opportunities, find common ground and achieve cooperation for business benefit
  • Knowledge and use of relevant PC software applications, PowerBI and skills to use them effectively.

 

-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.

 

Target Pay Range:  $115,900.00 to $144,900.00  -  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.


Nearest Major Market: Denver

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