This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management
Job Summary
This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management.
The successful candidate will own and execute GMP SDLC deliverables including validation documentation, testing protocols, and release planning.
You will join a global healthcare biopharma company with a 130-year legacy of success backed by ethical integrity and an inspiring mission.
Matching Summary
This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management.
Skills & Requirements
Must-have
GMP validation experience
SDLC execution expertise
Jira and Confluence proficiency
FDA and EMA regulatory knowledge
Risk-based validation approaches
Nice-to-have
Manufacturing intelligence platform support
SOP authorship and lifecycle sustainment
IT supplier management experience
Automated compliance tools knowledge
Digital transformation collaboration
Key Requirements
Bachelor's degree in Computer Science, Engineering, or Life Sciences
3+ years of experience in GMP validation or CSV/CSA methodologies
Strong understanding of FDA, EMA, and ICH regulatory frameworks