Posted in Other 30+ days ago.
This job brought to you by America's Job Exchange
Type: Full Time
Location: Greenville, South Carolina
This role performs a wide variety of compliance activities for Infor teams that develop, sell and support software products.The Compliance and Governance team owns the Infor QMS (Quality Management System) and works 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 9001, FDA 21 CFR 11 and ISO 27001, but we also support customers with requirements for TISAX, HIPAA, PCI, GDPR, SOX and other regulations as needed.General responsibilities include:
Work with teams to create policies, procedures and templates following a strict document control system.This requires working with teams who have no experience writing procedures and will need extensive coaching in order to produce effective working documents.
Perform internal audits of software development teams against ISO 9001, FDA validation requirements and ISO 27001.
Perform internal audits of other departments (primarily IT and SaaS) against ISO 9001 and ISO 27001.
Support 2ndparty (customer) audits of Infor by completing questionnaires and hosting on site audits.Most audits are for FDA validation (software development) or for security and privacy (SaaS).
Participate in 3rdparty audits of Infor.These audits currently include ISO 27001, TISAX, UK Cyberessentials, HIPAA, PCI and SSAE 18.
Participate in risk assessments, primarily for ISO 27001.
Participate in sales presentations when customers have validation questions.
Review software application requirements and designs for 21 CFR 11 electronic signature compliance.
Bachelor of Science in Engineering, Computer Science or related field
Experience working in a regulated environment and/or with regulated customers
Auditor certification a plus
US Citizen or Green Card holder
Ideal candidate will have an extensive background in either software development (especially Agile), IT systems, or SaaS
Communicate clearly and concisely to staff and customers who may be non-technical
Be proactive and able to act on own initiative without a fixed set of daily tasks
Be comfortable balancing multiple tasks in a position where priorities can shift quickly
Demonstrate professional presentation skills to both technical and non-technical audiences
Be an effective mentor and coach in the adoption of new procedures across various business units
Be passionate about process improvement and learning new standards/regulations
PREFERRED: KNOWLEDGE OF GAMP 5, FDA 21 CFR 11/ EU ANNEX 11, SOFTWARE VALIDATION, ISO 9001, ISO 13485, ISO 27001
TRAVEL ~1 AUDIT PER MONTH:International travel may be required.Must be able to travel to UK and EU without restriction.
TRAINING REQUIREMENTS: INFOR WILL PROVIDE EXEMPLAR GLOBAL CERTIFIED ISO 9001 AND/OR ISO 27001 LEAD AUDITOR TRAINING AS NEEDED, AT NO COST TO THE EMPLOYEE.
INFOR DOES NOT DISCRIMINATE IN EMPLOYMENT OPPORTUNITIES OR PRACTICES ON THE BASIS OF RACE, COLOR, CREED, RELIGION, SEX, GENDER IDENTITY OR EXPRESSION, SEXUAL ORIENTATION, NATIONAL ORIGIN, GENETICS, DISABILITY, MARITAL STATUS, AGE, VETERAN STATUS, PROTECTED VETERANS, MILITARY SERVICE OBLIGATION, CITIZENSHIP STATUS, INDIVIDUALS WITH DISABILITIES, OR ANY OTHER CHARACTERISTIC PROTECTED BY LAW APPLICABLE TO THE STATE IN WHICH YOU WORK.
IF YOU HAVE A DISABILITY UNDER THE AMERICANS WITH DISABILITIES ACT OR SIMILAR LAW, AND YOU WISH TO DISCUSS POTENTIAL ACCOMMODATIONS RELATED TO APPLYING FOR EMPLOYMENT AT OUR COMPANY, PLEASE CONTACT HUMAN RESOURCES AT 470-548-7173 AND/OR ADAAA@INFOR.COM APPLICANTS TO AND EMPLOYEES OF MOST UNITED STATES PRIVATE EMPLOYERS, STATE AND LOCAL GOVERNMENTS, EDUCATIONAL INSTITUTIONS, EMPLOYMENT AGENCIES AND LABOR ORGANIZATIONS ARE PROTECTED UNDER FEDERAL LAW FROM DISCRIMINATION.
FOR ADDITIONAL INFORMATION PLEASE SEE EEO IS THE LAW POSTER, THE EEO SUPPLEMENTAL AS WELL AS THE STATEMENT OF POLICY..