Compliance Manager, IT

Manager, It Process Governance

Manager, IT Process Governance manages the standardization of the IT product design, development, testing, implementation, security and operations processes for all products under the Customer Systems & Innovations portfolio. This role is also responsible for consulting on all RA / QA documentation for Corporate Systems & Innovation to meet and maintain internal RA / QA and FDA requirements and will be a key participant as needed in external audits, including those performed by the FDA.

Essential Duties and Responsibilities :

• Responsible to provide consultation services to leadership on design / development, security and quality assurance policy, procedure and implementation to ensure compliance with regulatory requirements, Customer Systems & Innovations standards and industry best practices. This includes managing change and alignment with cross-functional teams impacted by added or modified processes (Quality Assurance, Customer Care, Marketing, Customer Service, etc.).
• Provides direction and strategy to 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. This includes monitoring performance of projects as they enter and exit the Customer Systems & Innovations Project Management Office to identify and communicate continuous improvement opportunities for continued compliance.
• Responsible to 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 (FDA, ISO, MDSAP, HITRUST, etc.).
• Acts as Business Owner for design, development and testing tools such as Jira, Confluence and qTest to monitor the technology strategy on digital workflow process. This includes coordinating system upgrades and maintenance to ensure systems are maintained at a supported level and remain operational.
• Coordinates with IT Data Analysts to establish and maintain standardization across Customer Systems & Innovations organization on the use of design, development and testing tools. This includes development and monitoring of key performance indicators to support quality metrics for design, development and testing processes.
• Responsible to identify, solution, socialize and manage change of process improvements to support design, development and manufacturing processes for the Customer Systems & Innovations organization.
• Responsible to maintain business partnership with Sr. Manager, PMO to ensure continuous alignment between PMO and IT Governance teams. This includes collaboration on process improvement initiatives to continue to create efficiencies and mature the organization.
• Provides direction and strategy to Analysts, Security Compliance for WS Information Security Program (WSISP) improvement, implementation and operations. Responsible for continuous governance and compliance of HITRUST security controls to ensure they continue to be implemented correctly, operating as intended and producing the desired outcome with respect for meeting the cybersecurity requirements for assigned HITRUST pre / post certified systems.
• Perform manager-type responsibilities for direct reports (performance management, time reporting, expense management, etc.).

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