What are the responsibilities and job description for the Global QMS Specialist - Management Controls and QAD Compliance Program position at Terumo BCT?

Requisition ID : 33316

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.

As a Global Quality Management System (QMS) Specialist , you'll play a critical role in ensuring excellence in quality systems and regulatory compliance. As a key liaison between Terumo Blood and Cell Technologies (TBCT) and Terumo Corporation, you'll facilitate seamless communication, share insights on regulatory updates, and support global initiatives. This position involves collaborating with cross-functional and international teams to standardize processes, manage global QMS projects, and enhance quality metrics reporting. You'll also assist with inspections, audits, and document management while ensuring compliance with ISO and FDA regulations, and other global standards. If you're passionate about driving continuous improvement, fostering global collaboration, and contributing to impactful quality solutions in the medical device industry, this is the opportunity for you!

ESSENTIAL DUTIES

Works closely with cross-functional teams to ensure consistency in quality management processes, drive continuous improvement, and support global regulatory compliance efforts
Collaborates with global teams to drive standardization of procedures and policies across sites
Support global regulatory inspections and audits (external and internal) as requested
Assist with the creation and revision of QMS documents (includes but not limited to Policies, Standard Operating Procedures, Work Instructions) in accordance with internal requirements and industry best practices
Act as the liaison between TBCT Global Quality in the US and the corporate Quality Assurance Department (QAD).
Is the primary project manager for TBCT global quality projects and coordination

Management Controls and QAD Compliance Specific Duties :

Provide support for the inspection readiness program, including remediation project management, project communication, and executive reporting.

Works closely with Data Analytics to drive improvements for global quality metrics reporting.

Manage the portfolio of global quality projects to ensure delivery of organizational objectives, QMS enhancements, and QAD specific projects.

Develop, implement, maintain and execute Global Quality Plans.

Maintains Management Control process documents and procedures.

Manage the execution of Global Quality Management Review logistics and documentation.

Support Terumo Corp QMS and Shoki-Ryudo Assessments, including process improvements and training initiatives.

Maintains and owns the Global Management Responsibility List (including changes to PRRC [person responsible for regulatory compliance} quality appointment letters) and initiate changes when necessary by following the internal change control process.

Serves as a liaison between Terumo Corporate Quality and TBCT Quality. Shares information related to quarterly reports from Corpoarte Quality office (CQO), upcoming regulatory changes and performance reports, and ad-hoc requests.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree or equivalent experience in quality systems, regulatory compliance, and project management

Experience

Minimum 4 years experience.

Strong project management and coordination.

Experience in communication to all levels of the organization..

A strong working knowledge of QMS as it relates to 21 CFR Part 820 and ISO 13485.

Experience in a manufacturing environment preferred.

Skills

Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.

Knowledge of international standards and regulations, including ISO 9001, ISO 13485, FDA regulations, and other regional standards.

Experience in the medical device, pharmaceuticals, or manufacturing industries.

Demonstrated ability to communicate effectively both verbally and in writing.

Completes assigned tasks independently with a high level of accuracy.

Strong ability to adapt to changing global regulations and business needs.

Knowledge of relevant PC software applications and skills to use them effectively. Proficiency in tools like PowerBI, Smartsheet, and project management software prefered.

Ability to deliver strategic enhancements to quality systems and reporting tools.

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

LOCATION

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

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.

Target Pay Range : $86,000.00 to $107,800.00 - 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.

Salary : $86,000 - $107,800

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