Quality, Regulatory & Audit Specialist, Senior

Infor•Dallas, TX

34d•Hybrid

About The Position

Infor is looking for a Quality, Regulatory and Audit Specialist who will be responsible for performing a wide variety of compliance activities for Infor teams that develop, sell and support software products. The Quality, Regulatory & Audit team owns the Infor QMS (Quality Management System) and collaborates with all Infor departments. Our goal is to develop SOPs that meet our customers' needs as well as our own regulatory requirements. Most compliance topics are related to ISO 27001, ISO 9001, FDA 21 CFR Part 11, ISO 42001 and NIS2, but will also support customers with requirements for TISAX, CMMC, HIPAA, PCI, SOX and other regulations as needed. A Day In the Life Typically Looks Like: 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.

Requirements

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.

Nice To Haves

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.

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.

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