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IT Process Governance Manager

2 months ago

Lincolnshire Illinois, United States Sysmex Full time

About the Role:

We are seeking a highly skilled IT Process Governance Manager to join our team at Sysmex. As a key member of our organization, you will be responsible for managing the standardization of IT product design, development, testing, implementation, and operations processes for all products under the Customer Systems & Innovations portfolio.

Key Responsibilities:

  • Provide consultation services to leadership on design/development and quality assurance policy, procedure, and implementation to ensure compliance with regulatory requirements, Customer Systems & Innovations standards, and industry best practices.
  • Direct and strategize Analysts, IT Governance to consult, review, and ensure compliance with Sysmex Product Design and Development Process (PDDP) and Customer Systems & Innovations standards as independent reviewers.
  • Act as subject matter expert on design, development, and manufacturing of medical device products and supporting quality systems on behalf of Customer Systems & Innovations teams to support internal and external audits.
  • Act as Business Owner for design, development, and testing tools such as Jira, Confluence, and qTest to monitor the technology strategy on digital workflow process.
  • Coordinate with IT Data Analysts to establish and maintain standardization across Customer Systems & Innovations organization on the use of design, development, and testing tools.
  • Identify solutions, socialize, and manage change of process improvements to support design, development, and manufacturing processes for the Customer Systems & Innovations organization.
  • Maintain business partnership with Sr. Manager, PMO to ensure continuous alignment between PMO and IT Governance teams.
  • Perform manager-type responsibilities for direct reports (performance management, time reporting, expense management, etc.).

Requirements:

  • Bachelor's degree or 8+ years of previous experience in People and/or Process Management, QA and/or Compliance, QA Software Engineer, Business Analyst, Application Testing Processes required.
  • Master's degree preferred.
  • Working knowledge of ISO framework for Product Design & Development Processes for cloud application services.
  • Hands-on experience with audit preparation and running audit sessions for FDA, ISO, and/or Security audits.
  • Proven ability to work under stress in emergencies with flexibility to handle multiple high-pressure situations simultaneously.
  • Proven leadership abilities including effective knowledge sharing, conflict resolution, facilitation of open discussions, fairness, and displaying appropriate levels of assertiveness.
  • Ability to communicate highly complex technical information clearly and articulately for all levels and audiences.
  • High critical thinking skills to evaluate alternatives and present solutions that are consistent with business objectives and strategy.
  • Must demonstrate initiative and effective independent decision-making skills.
  • Office Suite (Word, Excel, PowerPoint, Outlook) and Atlassian Suite (Jira, Confluence, Zephyr) or similar tools highly desirable.
  • Tricentis qTest Suite.
  • Proven success in leading a team of resources in a high-paced environment to meet simultaneous critical deliverables.
  • Working knowledge of Agile methodology and software testing strategies.