Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders
Job Summary
Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders.
The Senior Specialist Quality Assurance, CSV role ensures GxP systems are implemented, validated, and maintained in compliance with regulatory and quality standards.
This position partners closely with IT and business teams to support system lifecycle activities, including vendor evaluations, software implementation, and system qualification.
Matching Summary
Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders.
Skills & Requirements
Must-have
GxP systems
21 CFR Part 11
Data Integrity standards
Software Development Lifecycle
Validation documentation
Risk-based validation processes
Nice-to-have
AI/ML-enabled systems
Continuous improvement
Cross-functional collaboration
Key Requirements
7+ years experience in pharmaceutical/biotech space