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Infor · 2 hours ago

Quality, Regulatory & Audit Specialist, Senior

Atlanta Metro

Full-time

Hybrid

Senior Level

Infor is a global leader in business cloud software products, and they are seeking a Quality, Regulatory and Audit Specialist. This role involves performing compliance activities, managing audit projects, and collaborating with various teams to ensure adherence to regulatory requirements.

Information and Communications Technology (ICT)Information ServicesManufacturingSoftware

Work & Life Balance

No H1B

Responsibilities

Work with teams to create and improve policies, procedures and templates following a strict document control system

Perform internal audits of software development teams and other departments (such as IT, SaaS, HR and customer support) against ISO 9001, against our SSDLC policy and ISO 27001. Manage audit projects, documentation, stakeholder communication, follow-ups

Building relationships with internal customers (Sales, Security, Development) to anticipate needs and understand risks

Support 2nd party (customer) audits of Infor by completing due diligence questionnaires and hosting virtual or on-site audits

Participate in 3rd party audits of Infor. These could relate to ISO 27001, ISO 42001, TISAX, HIPAA, PCI and SSAE 18

Participate, and contribute, in corporate risk assessments primarily for ISO 27001 and conduct gap analysis for compliance with new regulations against the ISO 27001 framework

Qualification

ISO 27001ISO 9001Internal auditsRisk assessmentsSaaS experienceISO auditor trainingProject managementCustomer interactionsSoftware validationDocumentation skills

Required

Control framework knowledge and documentation skills

A background in SaaS, software development, or IT systems

Prior experience with both internal and external audits

Prior experience conducting corporate risk assessments

Legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship now or in the future

Preferred

Experience working in a regulated environment and/or with regulated customers

Project management skills

Bachelor of Science in Engineering, Computer Science or Associate degree

ISO 9001/13485/27001 auditor training

Knowledge of one or more of the following: GAMP 5, FDA 21 CFR Part 11/ EU Annex 11, Software Validation, ISO 9001, ISO 13485, ISO 27001, ISO 42001, CMMC, HIPAA

Experience in customer interactions, sales support and/or coaching