QA Manager, Master Control System, Document Control and Training.
QA Manager, Master Control System, Document Control and Training
Location: London, UK
Reporting to: Director, Corporate Quality Assurance
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created three years ago, it is in an exciting phase where a Quality Assurance professional can have a real impact on the work and foundations that are being created.
This role will report to the Director, Corporate Quality Assurance located in Boston, MA and will be responsible for effective installation/configuration, operation and maintenance of the Orchard MasterControl Electronic Document Management System (EDMS),Learning Management Software (LMS), and Quality Management System (QMS).
The candidate will work closely with the software provider to resolve system issues, propose enhancements, deploy updates and test and implement additional functionality within the system.
This role will also be responsible for company document control including training to assure regulatory compliance.
Develop and maintain installation and configuration management procedures. Contribute to and maintain system standards. Follow-up on support issues proactively to provide timely updates and resolutions to end users. Work with vendor to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed. Work with the IT and validations teams to apply application version upgrades in a timely manner. Configure/add new services as needed. User administrator, including creating, changing and disabling user accounts per approved procedures. Work with existing process owners to deploy new modules, providing advanced training to support process owners becoming module power users. Work to develop reports, based on needs of end users and mana...