Job Summary
An international biopharmaceutical firm is seeking a Remote Senior IS Compliance Specialist Manager.
Candidates will be responsible for the following:
- Coordinating & supporting qualification & validation activities to enable IS Compliance Service delivery in support of Global IS Roadmap
- Facilitating, executing & implementing Quality Risk Management & defining controls/mitigations etc for Computerized Systems
- Generating, reviewing and/or approving validation deliverables during project implementations & ongoing system operations
Must meet the following requirements for consideration:
- 8 years’ experience working in IT compliance or computer system validation role within pharmaceutical, regulated or ISO environment
- Knowledge and understanding of IT best practices and IT quality Management Systems (such as ITIL, ISO)
- Knowledge of testing methodologies and Familiarity with automated testing techniques
- Understanding of QRM and Risk Based methodologies
