Manager, Quality Training & Document Control Systems Compliance

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This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.

...to improve the lives of others.

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.

...to build a promising future. 

We currently have a great opportunity available for a Manager, Quality Training & Document Control Systems Compliance. This position oversees the optimization and maintenance of GMP compliance quality training and document control systems, and associated processes across the enterprise. This position is responsible for management of direct report(s) with administrative responsibilities maintaining existing learning management (LMS) and content management (CMS) systems. As subject matter expert for the Learning and Content Management Systems, this position will interact with both internal and external regulatory bodies such as the FDA, HC, ISO, as well as suppliers and customers during audits. The position also has responsibility for providing leadership for the Sysmex credentialing process.

Essential Duties and Responsibilities:

1. Leads an organization of 1 to 5 Quality Specialists / Contractors to successfully manage Sysmex QA Training, Document Control, and Credentialing processes and enterprise systems.
2. Serves as the Subject Matter Expert (expert user) for the Sysmex Learning Management System (LMS) and Document Control (CMS) systems.
3. Ensures that compliant training curricula have been developed and implemented for all roles in the business.
4. Develops, implements, and monitors metrics / key performance indicators to ensure that the training process is compliant and effective.
5. Responsible for processing LMS and CMS system releases in accordance with Sysmex change management requirements, includes assessment of change, and determination of validation & testing.
6. Works globally when requested to share services and best practices with other Sysmex business entities.
7. Responsible for the management and improvement of the company-wide credentialing process, including vendor management (credentialing agencies) and interface with customer facilities and associates (both internal and field-based) who are identified as needing credentialing.
8. Represents the Quality organization as part of new hire on-boarding, as needed.
9. Supports Senior QA Management in defining and managing budget for the Learning, Content Management System, and Credential managed services systems.
10. Other duties as assigned.

Percentage of Travel: 0-5%

• Bachelor’s degree required; Learning and Development, Psychology or Organizational Development a plus.

• 5 or more years of previous experience in a regulated environment required, Including experience in the Armed Forces.

• Knowledgeable of and experience with working in a compliance driven environment.

• Knowledgeable of ISO, FDA and Canadian Medical Device regulations affecting training systems.

• English

• Microsoft Word, Excel, Powerpoint, Outlook.

• Technical Expertise in Enterprise Systems:
  • Knowledgeable of what constitutes an overall compliant and effective Learning and Content Management systems.
  • Ability to articulate effective system attributes such that business partners understand in their context.
  • Ability to design, implement and maintain effective system attributes to meet business and GMP requirements.
  • Knowledgeable of learning and content management systems architecture and interface requirements.
  • Ability to present training to diverse audiences.
  • Ability to read, analyze and interpret technical and regulatory literature and journals, and governmental legislation and regulations.
  • Ability to write reports, business correspondence, and policy and procedure manuals.
  • Ability to effectively present information in written form, or for presentation to management, employees, customers, or regulatory agencies
  • Experience in ISO and FDA audits

   

The salary range for this role is $92,000 - $145,200. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.