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

• Demonstrates strong ownership, accountability, and ability to operate independently
• Leads with integrity and fosters a collaborative "One Team" culture
• Comfortable in a fast-paced environment, demonstrating sound judgment and risk mitigation
• Strong organizational skills with the ability to manage multiple priorities
• Excellent communication skills across technical, operational, and executive audiences
• 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
  
  

Employment at Bryllan (Biovire) is contingent upon a successful Background check.