Summary / Objective
The IT Infrastructure Compliance Specialist supports the IT Infrastructure Compliance Officer with the administration, monitoring, and continuous improvement of the IT Infrastructure Compliance Management Program. This role coordinates compliance activities, reporting, investigations, corrective actions, audits, validation support, documentation, training, knowledge management, and risk management across North America and global operations.
Essential Functions
Key duties and responsibilities include:
- Support administration of the IT Infrastructure compliance program for applicable regulatory, contractual, customer, privacy, quality, training, document management, risk management, and corporate requirements.
- Coordinate infrastructure qualification and validation activities for systems and services supporting GxP-regulated environments, including GAMP-based validation deliverables and lifecycle documentation.
- Develop, review, revise, route, and maintain controlled IT Infrastructure policies, procedures, standards, work instructions, validation documents, compliance records, and related eQMS training requirements.
- Govern ITSM knowledgebase content to ensure support articles, runbooks, end-user guidance, technical procedures, and FAQs remain accurate, current, searchable, and aligned with approved controlled documents.
- Identify, assess, document, monitor, and report compliance-related risks affecting Infrastructure services, operational processes, validation activities, documentation, training, customer obligations, and regulatory requirements.
- Administer the IT Infrastructure support team IT Risk Register, coordinate mitigation plans and action owners, track remediation progress, and escal significant or overdue risk treatment activities.
- Promote ITIL-aligned service management practices across Infrastructure Operations to improve service quality, compliance reliability, knowledge availability, operational stability, and risk reduction.
- Develop and manage compliance awareness and training materials related to regulations, risk management, GAMP requirements, validation responsibilities, eQMS document requirements, ITSM knowledgebase use, and ITIL-aligned practices.
- Support internal audits, external audits, customer audits, regulatory inspections, validation assessments, document control reviews, training reviews, and compliance reviews.
- Coordinate investigations, root cause analysis, corrective and preventive action plans, risk action plans, documentation remediation, training remediation, and effectiveness verification activities.
- Serve as a liaison between Infrastructure Operations and Information Security, Privacy, Legal, Quality Assurance, Risk Management, IT Solutions, Service Management, eQMS administrators, Knowledge Management stakeholders, GSC IT Risk, GSC Risk, and Customer Support teams.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
- Perform other duties as assigned in support of IT Infrastructure compliance and related program objectives.
- Support audits, inspections, customer engagements, trainings, and business meetings as required.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change at any time with or without notice.
Competencies
Core competencies required for this role include:
- Strong analytical and investigative capabilities with advanced root cause analysis skills.
- Strong understanding of GAMP-based validation methodologies, computerized system validation, and validation lifecycle management.
- Ability to interpret and apply regulatory, privacy, quality, risk, and customer requirements within technical infrastructure environments.
- Strong understanding of ITIL-based service management principles, including Knowledge Management and operational governance.
- Ability to design and monitor governance frameworks for compliance, risk, documentation, and knowledge management.
- Experience developing compliance metrics, dashboards, scorecards, and management review materials.
- Excellent stakeholder management, facilitation, presentation, training delivery, technical writing, and communication skills.
- Exceptional attention to detail and ability to manage multiple compliance, documentation, training, knowledgebase, and risk initiatives.
- High ethical standards and commitment to regulatory excellence, quality, service reliability, risk reduction, and customer trust.
Required Education and Experience
- Bachelor's degree in Information Technology, Information Systems, Computer Science, Cybersecurity, Business Administration, Quality Management, Regulatory Affairs, Risk Management, Technical Writing, Knowledge Management, or related field; equivalent combination of education and relevant experience may be considered.
- Minimum 5 years of experience in IT, IT Inf