The Senior Specialist role serves as a business partner to the IT team, proposing innovative solutions to enable new organizational capabilities
Job Summary
The Senior Specialist role serves as a business partner to the IT team, proposing innovative solutions to enable new organizational capabilities.
This position is responsible for administering regulatory compliance programs, conducting risk assessments, and managing remediation of IT/OT compliance risks.
The incumbent will represent compliance activities to auditors, support audit responses, and champion changes to SDLC policies across global sites.
Matching Summary
The Senior Specialist role serves as a business partner to the IT team, proposing innovative solutions to enable new organizational capabilities.
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
Strategic thinking with ambiguity tolerance
Key Requirements
Bachelor's Degree in Computer Science or related field
5+ years supporting compliance activities
Knowledge of 21CFR Part 11 and EMEA Annexes
Experience in pharmaceutical manufacturing quality areas