The role involves administering regulatory compliance programs while championing a risk-based and lean approach to IT/OT compliance activities
Job Summary
The role involves administering regulatory compliance programs while championing a risk-based and lean approach to IT/OT compliance activities.
Candidates will represent the organization to internal and external auditors, supporting audit responses and engaging with local quality organizations.
This position requires executing risk assessments for new technologies and reporting on deviations, CAPAs, and adherence to procedural trends.
Matching Summary
The role involves administering regulatory compliance programs while championing a risk-based and lean approach to IT/OT compliance activities.
Skills & Requirements
Must-have
5+ years compliance activities experience
21CFR Part 11 regulatory knowledge
EMEA Annex 11 regulatory requirements
ISA S95 and S88 standards application
Cloud and SaaS validation expertise
Internal and external auditor management
Nice-to-have
Post Graduate qualification in Business Strategy
Cross industry collaboration experience
Real-time shopfloor system integration
Manufacturing analytics systems knowledge
Business process re-engineering principles
Advanced image analysis exposure
Key Requirements
Bachelor's Degree in Computer Science or related field