Manager IT & Information Systems

Department: FinanceLocation: Brighton, MichiganJob Title: Manager IT & Information SystemsROLE SUMMARYBiovire 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.KEY RESPONSIBILITIESThe Manger IT & Information Systems will report to the Chief Financial Officer and work cross-functionally with Quality, Operations, Engineering, and Manufacturing.IT Operations & GovernanceOversee IT asset provisioning and lifecycle management, including end-user equipment setup, deployment, tracking, and decommissioningDevelop standardized onboarding and offboarding technology workflows in partnership with HR and FinanceManage vendor relationships for IT hardware, software, and support servicesSupport implementation and maintenance of IT policies and controls appropriate for a regulated manufacturing environmentLead annual IT SOx compliance program lifecycle, including risk assessment, scoping, control design, testing & remediation.Information Systems OwnershipManage and support core business and operational systems including:Access databasesBuilding Automation Systems (BAS)Madgetech data logger systemsMaintenance spare parts inventory management systemsOversee Excel spreadsheet validation and governance, including risk assessment and documentationDevelop dashboards, KPIs, and reporting to support operational visibility and decision-makingOwn vendor management, system onboarding, and lifecycle management for IT and IS platformsIT Security & Access ControlManage logical access controls, including user account provisioning and deprovisioning across business and GMP systemsAdminister network access, permissions, and system authentication controlsPartner with Site Security to ensure alignment between physical and logical access controlsSupport audit readiness related to system access, permissions, and data integritySystem & Industry ExpertiseLead CSV onboarding and support across manufacturing and automation platforms including:MES, DCS, SCADA, batch systemsSupport onboarding and validation of major platforms such as:Rockwell, Allen Bradley, Siemens, Emerson, GE, ABB, HoneywellPAS-X, FactoryTalk, FactoryLogixPI, PLM, Simatic, iFix, WonderwareOwn 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 decommissioningOrganizational AlignmentLead development and maintenance of IT/IS policies in partnership with Finance and QualityParticipate in audits and inspections as subject matter expert for IT and validated systemsContribute technical input to future system planning and upgradesBehavioral Expectations: 1. Demonstrates strong ownership, accountability, and ability to operate independently2. Leads with integrity and fosters a collaborative "One Team" culture3. Comfortable in a fast-paced environment, demonstrating sound judgment and risk mitigation4. Strong organizational skills with the ability to manage multiple priorities5. Excellent communication skills across technical, operational, and executive audiences6. High ethical standards and commitment to complianceREQUIRED KNOWLEDGE, SKILLS & EDUCATIONThis 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§ Minimum5 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 desirableProfessional & 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 cultureEmployment at Bryllan (Biovire) is contingent upon a successful Background check.

Salary : $94,600 - $111,900