Head IT & Information Systems

Department: Finance

Location: Brighton, Michigan

Job Title: Head IT & Information Systems

ROLE SUMMARY

Biovire is creating a new Head IT & Information Systems role to provide technical leadership and hands-on support across IT operations, regulated computer systems, and site-level digital infrastructure in support of clinical-stage operations and future commercialization.

This role will be responsible for overseeing IT operations, GMP-compliant/SOX-compliant computer systems and processes, system validation activities, and technology enablement across Manufacturing, Quality, Engineering, and Operations. The position will ensure that systems are fit-for-purpose, compliant, secure, and scalable as the organization grows.

KEY RESPONSIBILITIES

The Head IT & Information Systems will report to the Chief Financial Officer and work cross-functionally with Quality, Operations, Engineering, and Manufacturing.

IT Operations & Governance

• Oversee IT asset provisioning and lifecycle management, including end-user equipment setup, deployment, tracking, and decommissioning
• Develop standardized onboarding and offboarding technology workflows in partnership with HR and Finance
• Manage vendor relationships for IT hardware, software, and support services
• Support implementation and maintenance of IT policies and controls appropriate for a regulated manufacturing environment
• Lead annual IT SOX compliance program lifecycle, including risk assessment, scoping, control design, testing & remediation.

Information Systems Ownership

• Manage and support core business and operational systems including:
  • Access databases
  • Building Automation Systems (BAS)
  • Madgetech data logger systems
  • Maintenance spare parts inventory management systems
• Oversee Excel spreadsheet validation and governance, including risk assessment and documentation
• Develop dashboards, KPIs, and reporting to support operational visibility and decision-making
• Own vendor management, system onboarding, and lifecycle management for IT and IS platforms

IT Security & Access Control

• Manage logical access controls, including user account provisioning and deprovisioning across business and GMP systems
• Administer network access, permissions, and system authentication controls
• Partner with Site Security to ensure alignment between physical and logical access controls
• Support audit readiness related to system access, permissions, and data integrity

System & Industry Expertise

• Lead CSV onboarding and support across manufacturing and automation platforms including:
  • MES, DCS, SCADA, batch systems
• Support onboarding and validation of major platforms such as:
  • Rockwell, Allen Bradley, Siemens, Emerson, GE, ABB, Honeywell
  • PAS-X, FactoryTalk, FactoryLogix
  • PI, PLM, Simatic, iFix, Wonderware
• Own IT general controls and SOX compliance by:
  • Executing IT General Controls (ITGCs) supporting SOX compliance.
  • Maintaining SOX documentation and respond to assigned audit requests.
• Provide technical and compliance guidance during system selection, implementation, upgrades, and decommissioning

Organizational Alignment

• Lead development and maintenance of IT/IS policies in partnership with Finance and Quality
• Participate in audits and inspections as subject matter expert for IT and validated systems
• Contribute technical input to future system planning and upgrades

Behavioral Expectations:

1. Demonstrates strong ownership, accountability, and ability to operate independently

2. Leads with integrity and fosters a collaborative "One Team" culture

3. Comfortable in a fast-paced environment, demonstrating sound judgment and risk mitigation

4. Strong organizational skills with the ability to manage multiple priorities

5. Excellent communication skills across technical, operational, and executive audiences

6. High ethical standards and commitment to compliance

REQUIRED KNOWLEDGE, SKILLS & EDUCATION

This is a key technical role within the organization; therefore, the expectations and credentials of the candidate are demanding. The educational requirements represent the minimum for this position:

Qualifications & Experience

§ Bachelor's degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be considered

§ Minimum 5+ years of experience in IT or computer systems validation within a regulated environment;

§ Experience in biotech or pharmaceutical manufacturing environments strongly preferred

§ Working knowledge of GAMP 5 guidelines and FDA regulations (21 CFR Parts 11, 210, 211)

§ Working knowledge IT General Controls (ITGCs) and supporting SOX compliance activities, including audit support and remediation.

§ Experience supporting automation, manufacturing execution, or enterprise systems (MES, SCADA, DCS, etc.)

§ Experience with managing ERP Systems (i.e..NetSuite, SAP, Microsoft Dynamics)

§ Data integrity assessment and remediation experience is highly desirable

Professional & Leadership Competencies

§ Demonstrates strong ownership, accountability, and ability to operate independently

§ Excellent verbal and written communication skills across technical and executive audiences

§ Strong organizational skills with ability to manage multiple priorities in a dynamic environment

§ Ability to influence cross-functionally and build trust across departments

§ Comfortable interacting with auditors and regulatory inspectors

§ High ethical standards and commitment to compliance and data integrity

§ Fosters a collaborative, respectful, and team-oriented culture