Manager, IT -GxP Systems & Compliance

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you’ll love working at Axogen:

Friendly, open, and fun team culture that values unique perspectives

Company-wide dedication to profoundly impacting patients’ lives

Comprehensive, high-quality benefits package effective on date of hire

Educational assistance available for all employees

Matching 401(k) retirement plan

Paid holidays, including floating holidays, to be used at your discretion

Employee Stock Purchase Plan

Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Manager IT, GxP Systems & Compliance

The Manager IT, GxP Systems & Compliance serves as the senior technology leader for Axogen's Ohio manufacturing facility, providing leadership for onsite technology personnel and acting as the primary liaison between plant leadership and Corporate IT. Reporting to the Senior Director of IT, this role oversees and coordinates Operational Technology, infrastructure, cybersecurity, manufacturing applications, vendors, and enterprise IT resources to ensure reliable operations, regulatory compliance, project execution, and operational excellence. The Manager partners closely with Manufacturing, Quality, Engineering, Facilities, Laboratory, and Operations leaders to align technology priorities with business needs, coordinate activities with production schedules, remove barriers to execution, and minimize operational disruption. The role also leads technology planning team and vendor coordination for facility expansion, workforce growth, infrastructure modernization, and manufacturing system initiatives, ensuring technology capabilities support both current operations and long-term business objectives.

Requirements of the Manager IT, GxP Systems & Compliance

Bachelor's degree in Information Systems, Computer Science, Engineering, Biotechnology, or a related discipline; or 8 years of related experience will be considered.

Minimum 7 years supporting enterprise, manufacturing, operational technology, computerized, or regulated systems.

Minimum 3 years of experience leading technical teams, managing vendor relationships, coordinating cross-functional resources, or directing technology projects in a manufacturing or regulated environment.

Experience with regulated production environments, system implementations, vendor management, facility technology, change control, validation support, and compliance documentation.

Strong communication, prioritization, relationship-management, and follow-through skills across plant leadership, operational teams, IT, contractors, and vendors.

Preferred knowledge of GxP, 21 CFR Part 11, validation, electronic records, manufacturing applications, low-voltage infrastructure, wireless networking, and OT cybersecurity.

Responsibilities of the ManagerIT, GxP Systems & Compliance

The specific duties of the ManagerIT, IT Systems & Compliance include but are not limited to:

Serve as the senior onsite IT and Operational Technology (OT) leader and primary liaison between plant leadership, Corporate IT, and business stakeholders. Translate operational priorities, risks, strategic initiatives, and business needs into aligned technology roadmaps, support strategies, and execution plans.

Lead and develop the OT support team, establishing priorities, workload plans, escalation processes, support coverage, documentation standards, and service expectations while coordinating the efforts of Corporate IT personnel, application owners, vendors, contractors, and site resources regardless of reporting relationships.

Oversee operational support, maintenance, and lifecycle management of manufacturing technology systems. Maintain visibility to preventive maintenance, backups, incidents, changes, CAPAs, MOC activities, projects, and support activities, ensuring work is properly prioritized, documented, executed, and audit ready.

Direct technology planning and execution for site growth, infrastructure initiatives, and digital transformation efforts. Manage technology vendors and implementation partners while coordinating resources, schedules, dependencies, testing, installations, turnover activities, and technology investments that improve operational efficiency, data integrity, traceability, and business processes.

Partner with Production, Quality, Validation, Engineering, Facilities, and other stakeholders to govern technology changes, new system implementations, validation activities, CAPA resolution, and change control processes. Ensure alignment with enterprise architecture, cybersecurity requirements, IT policies, and regulatory expectations while supporting audit readiness and compliance.

Collaborate with Quality, Validation, and Corporate IT to maintain GxP, Part 11, data integrity, cybersecurity, disaster recovery, business continuity, and risk management programs across the OT environment.

Establish and maintain documentation, governance, and lifecycle standards, ensuring inventories, diagrams, procedures, runbooks, access records, maintenance histories, validation documentation, and technical records remain current, accurate, and audit ready.

Manage vendor performance, service levels, budgets, contracts, renewals, capital planning, forecasting, and technology investment priorities in partnership with the Senior Director of IT.

Location

913 Industrial Park Dr, Vandalia, OH 45377

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Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range

$113,903 — $142,378 USD

Company Statements

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

As AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific