at Terumo BCT
Posted on Aug. 25, 2017
JOB TITLE: QUALITY MANAGEMENT SYSTEM GLOBAL PROCESS OWNER - QUALITY GOVERNANCE
Leads the specified global process for the Quality Management System(QMS). Manages a team of direct and indirect reports in a Matrix organization to manage all aspects of the global process. Guides the organization in the appropriate use of the processes and procedures. Is the subject matter expert on all relevant regulations in the markets we serve. Creates or updates procedures to meet these regulations changes. r Working with the Director, creates the vision for a refined future state process and works to continually improve.
* Acts as the global policy / procedure owner for areas of responsibility, ensuring they are compliant and effective
* Leads Collaboration (Centers of Excellence) groups with site process owners to ensure process consistency at all sites.
* Serves as expert and main point of contact for regulatory / compliance issues within areas of responsibility
* Ensures execution in accordance with policies / procedures and external standards and regulations. This likely includes: generation and approval of schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
* Monitors the health of the QMS and monitors site and corporate metrics to demonstrate continuous compliance
* Identifies and implements continuous improvement opportunities within their areas of responsibility
* Influences the organization in quality objectives, prioritization and resourcing decisions
* Manages and provides operational leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
* Acts as a champion for quality initiatives aimed at improving business systems and compliance; may be the primary Quality representative on projects
* During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for Quality
* Interfaces with global and site QMS process owners and project teams from all Terumo BCT locations & regions to ensure consistency in approach and inspire continual improvement of processes.
* Stay up to date on current interpretation of GMPs
MINIMUM QUALIFICATION REQUIREMENTS
Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
* 7 years experience in Quality Assurance, Regulatory Affairs with US FDA Class II or Class III medical devices, Pharmaceuticals, combination products and the worldwide equivalents.
* Interpretation and application of global regulation changes to quality systems
* Experience leading diverse global teams through significant change
* Knowledge of U.S. and international medical device and pharma regulations and standards (CFR 820, 210, 211 MDD/MDR and ISO 13485, 14971)
* Demonstrated ability to work with cross functional teams to influence, mentor and incorporate team's recommendations.
* Ability to coordinate and lead cross functional team through influence through direct authority and/or technical leadership.
* Ability to lead projects across regions and functions
* Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
* Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
* Demonstrated ability to communicate effectively both verbally and in writing.
* Knowledge and use of relevant PC software applications and skills to use them effectively.
* Must be detail oriented, well organized and able to work independently and in teams.
* Demonstrated ability to lead people and get results through others.
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 domestic and international travel based on business needs Up to 10-30 %
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, 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.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers .
JOIN TERUMO BCT AS WE UNLOCK THE POTENTIAL OF BLOOD. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
Our company has almost $1B in annual revenues and has been voted and recognized as:
* Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
* Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
* One of Colorado's Healthiest Employers by Denver Business Journal (2014 & 2015)
* Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015
Our award-winning culture embraces:
* Leading technology through innovation and R&D
* Wellness programs
* Commitment to quality
* An environment that values, respects and rewards your individual contributions
* A philosophy of intentional growth and responsiveness to world health issues
Click Here to see what our associates have to say about our culture.
Each associate has a positive impact on our future by:
* Connecting to the lives of the patients we ultimately serve
* Growing through professional and leadership development activities
* Sharing company success through incentive plans
IF YOU ARE THE BEST AT WHAT YOU DO AND WANT TO DO WORK THAT IS CHANGING THE DELIVERY OF HEALTHCARE GLOBALLY, WE INVITE YOU TO WORK WITH US NOW TO SEE HOW WE CAN UNLOCK YOUR POTENTIAL.