The IT Compliance & CSV Senior Manager is responsible for the development, maintenance and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies
Job Summary
The IT Compliance & CSV Senior Manager is responsible for the development, maintenance and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies.
This role partners with Business Units, IT teams, Quality, and Regulatory functions across multiple geographies to define computer system validation requirements and ensures IT project delivery, application management, change management and quality management solutions are managed in compliance with Pharmaceutical and Manufacturing industry regulations.
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do, including competitive PTO, annual bonus, 401(k) with profit-sharing, and comprehensive health benefits.
Matching Summary
The IT Compliance & CSV Senior Manager is responsible for the development, maintenance and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies.
Skills & Requirements
Must-have
Computer Systems Validation (CSV) expertise
Global policies and procedures
IT Governance oversight
GxP, GAMP, FDA 21 CFR Part 11, EU Annex 11
IT risk reviews and mitigation
IT change control compliance
Nice-to-have
Customer and results orientated
Effective communication and team skills
Support, diagnostic and problem-solving skills
Flexibility in thinking/action
Pragmatic in solving problems
Key Requirements
Bachelor’s Degree in Scientific or technical discipline
7+ years in pharmaceutical business processes
7+ years dealing with pharmaceutical industry regulations
7+ years in a Computer Systems Validation (CSV) role