The role serves as a business partner proposing innovative IT solutions to enable new organizational capabilities across EMEA and AP regions
Job Summary
The role serves as a business partner proposing innovative IT solutions to enable new organizational capabilities across EMEA and AP regions.
Primary responsibilities include administering regulatory compliance programs, executing risk assessments for new technologies, and managing audit responses with internal and external agencies.
Candidates must demonstrate the ability to champion continuous maturity in compliance activities using a risk-based and lean approach while collaborating with global stakeholders.
Matching Summary
The role serves as a business partner proposing innovative IT solutions to enable new organizational capabilities across EMEA and AP regions.
Skills & Requirements
Must-have
5+ years compliance activity experience
21CFR Part 11 regulatory knowledge
EMEA Annex 11 compliance expertise
ISA S95 and S88 standards application
Cloud and SaaS validation skills
Internal and external auditor management
Nice-to-have
Post Graduate qualification in Business Strategy
Pharmaceutical manufacturing industry background
Real-time shopfloor system integration
Manufacturing analytics systems experience
Business process re-engineering principles
Cross-industry collaboration experience
Key Requirements
Bachelor's Degree in Computer Science or related field