What are the responsibilities and job description for the Quality & Regulatory Affairs Specialist, Senior position at Infor?
This role performs a broad set of compliance, audit, and regulatory activities for Infor teams that develop, deploy, sell, and support software products. You will lead and participate in internal audits (ISO 27001, ISO 9001, SSDLC), drive process improvements, own SBOM/product security compliance activities, serve as a SME for certain compliance activities for applicable products (e.g. ESG/Sustainability, PCI, and TISAX). The Quality, Regulatory & Audit (QRA) team owns the Infor Quality Management System (QMS) and collaborates across the organization to ensure SOPs and evidence meet customer and regulatory requirements (ISO standards, healthcare, financial services, and other applicable industry frameworks).
A Typical Day in the Life Includes:
- Plan, perform, and manage internal audits for product, deployment, support, and infrastructure teams (including Infor data centers and facilities) against ISO Standards and other applicable frameworks; drive closure of CAPAs and audit follow-ups.
- Build and maintain strong relationships with internal stakeholders (Development, Security, Sales, IT, SaaS teams, support) to anticipate needs and align risk and compliance work with business priorities.
- Support and coordinate 2ndparty (customer) audits and duediligence responses; host virtual or onsite customer audits and assist with 3rdparty audits.
- Support external certifications (SOC 1/2, ISO 27001/42001, PCI DSS); maintain audit-ready evidence and documentation to reduce business disruption.
- Participate in risk assessments and lead gap analyses for new or changed regulatory requirements.
- Create and continuously improve policies, procedures, templates, and SOPs under strict document control, and manage document control for organization information.
- Collaborate with project initiatives and crossorganizational teams to improve process flows, provide toolspecific training/demos, and optimize QRA value.
- Apply principlebased management (PBM) across activities and adhere to company values, ethics, and safety policies.
Basic Qualifications:
- Controlframework knowledge and documentation skills.
- Demonstrated experience conducting and leading internal audits (ISO 27001/ISO 9001/SSDLC).
Background in SaaS, software development, IT systems and familiarity with technical stakeholders. - Proven ability to manage multiple priorities in a fastpaced environment.
- Familiarity with AI technologies and AI prompt engineering concepts, with the ability to leverage AI tools to improve efficiency and quality outcomes.
Preferred Qualifications:
- Experience supporting industry-specific regulatory compliance requirements (healthcare, financial services, automotive, etc.
- SBOM (software bill of materials) and product security compliance experience (tools, workflows, and stakeholder management).
- Direct TISAX or automotive compliance experience.
- ISO 9001/27001 auditor training or equivalent audit certifications.
- Project management skills and experience leading crossfunctional initiatives.
- Knowledge of software validation methodologies, FDA regulations, or other relevant industry standards.