Manager IT & Information Systems

Biovire • Brighton, MI

2d

About The Position

Biovire is creating a new Manager 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.

Requirements

• 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
• 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)
• 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

Nice To Haves

• Experience in biotech or pharmaceutical manufacturing environments strongly preferred
• Data integrity assessment and remediation experience is highly desirable

Responsibilities

• 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.
• 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
• 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
• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees