Global Process Owner, QMS - Document and Change Controls

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Date: Mar 27, 2024

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  31703  

 

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. 

As a global process owner, this role provides Quality Management System (QMS) leadership within Terumo Blood and Cell Technologies (BCT) to monitor, maintain and continuously improve processes and supporting technology with respect to Quality Management System (QMS) Elements. This is a key leadership role responsible for communicating and contributing to the development of Terumo BCT’s standardized QMS best practices. This role involves developing and implementing strategies to ensure compliance with regulatory requirements, maintaining integrity, and managing change effectively across the organization.

 

ESSENTIAL DUTIES

  • Serves as the global process owner and a subject matter of expert for global regulations, document, and change controls within the QMS area of expertise.
  • Spearheads the global process consistent with regulatory and industry best demonstrated practices.
  • Strategically plan and set the stage for future improvements within the QMS.
  • Develops, implements, and continuously improves standardized processes for QMS document creation, approval, distribution, and change control.
  • Ensures adherence to relevant regulatory standards and industry best practices.
  • Oversees the creation, review, approval, and maintenance of all organizational documents, including policies, procedures, specifications, and work instructions.
  • Implements a robust document control system to ensure version control, accessibility, and traceability of QMS documents.
  • Develops and implement change control procedures to manage changes to documents, processes, and systems.
  • Facilitates the review and approval of change requests, ensuring thorough impact assessments.
  • Collaborates with regulatory affairs function to stay informed about changes in regulations and updates processes accordingly.
  • Collaborates with cross-functional teams to understand and document needs across various departments and regions.
  • Understands change management and drives changes to align with best demonstrated practices.
  • Communicates effectively with stakeholders to be able to influence and create a solid understanding of the QMS process.
  • Establishes key performance indicators (KPIs) to measure the effectiveness of the quality system element.
  • Develops process workflow and procedure improvements to deploy, teach and coach teams across the globe.
  • Develop and maintain training material to ensure compliance of the QMS Element training program.
  • Responsible for communication and coordination with business functions, site process owners and site leadership for implementation of process and applicable technology changes.
  • Effectively manages, resolves and/or escalates QMS-related implementation and/or interpretation issues in a timely fashion for quick resolution.
  • Effectively works with all global process owners to ensure a seamless QMS implementation, interpretation and understanding by the Terumo BCT organization.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

  • Bachelor's degree in a relevant engineering or scientific field required.

 

Experience

  • Minimum 10 years of experience in Quality, Regulatory Affairs, Manufacturing or Engineering within regulated industry (medical device or pharmaceutical).
  • Knowledge and experience interpreting and applying global regulations and standards for QMS (FDA, ISO, EU MDR and/or quality requirements associated with developing medical devices and combination products).
  • Demonstrated experience working with, influencing and/or leading global teams required.
  • Experience working with electronic document management systems required.
  • Experience working in a manufacturing environment is highly preferred.
  • Knowledge and experience working within a Quality Management System, integration of QMS elements and expectations of the organization to meet QMS requirements.

 

Skills

  • Strong strategic thinker capable of developing, implementing, and sustaining a globally standardized QMS process.
  • Strong leadership, communication, and interpersonal skills.
  • Ability to challenge status quo and demonstrate a growth mindset.
  • Ability to work collaboratively and influence stakeholders at all levels.
  • Solicits and accepts 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 collaborate with peers as needed to implement improvements to the QMS processes and applicable tools.
  • Knowledge and use of relevant PC software applications, PowerBI and skills to use them effectively.

 

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 Requirements

International travel is required 25% of the time.

 

Target Pay Range:  $99,200.00 to $124,000.00  -  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:  7.0%

 

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

Job Segment: Document Management, Medical Device, Pharmaceutical, Substance Abuse, Behavioral Health, Technology, Healthcare, Science

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