Compliance Manager, IT

POSITION SUMMARY: 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:

1. 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.).

2. 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.

3. 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.).

4. 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.

5. 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.

6. Responsible to identify, solution, socialize and manage change of process improvements to support design, development and manufacturing processes for the Customer Systems & Innovations organization.

7. 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.

8. 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.

9. Perform manager-type responsibilities for direct reports (performance management, time reporting, expense management, etc.).

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

• Bachelor's degree and 5 years required experience in People and/or Process Management, QA and/or Compliance, QA Software Engineer, Business Analyst, Application Testing Processes, including experience in the Armed Forces
• 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
• Working knowledge of ISO framework for Product Design & Development Processes for cloud application services and/or software security standards (ISO, NIST, OWASP, etc.)
• 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

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.