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.
You will own and execute GMP SDLC deliverables including validation documentation, testing protocols, and release planning while collaborating with cross-functional teams.
Join a global healthcare biopharma company with a 130-year legacy driven by ethical integrity and a mission to achieve new milestones in global healthcare.
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/EMA regulatory knowledge
Risk-based validation approach
Nice-to-have
Manufacturing intelligence platform support
SOP authorship and lifecycle sustainment
IT Supplier Management knowledge
Automated compliance tools experience
Digital SDLC platform familiarity
Key Requirements
Bachelor's degree in Computer Science, Engineering, or Life Sciences
3+ years of experience in GMP validation or CSV/CSA methodologies