| This role has overall Accountability for Quality and Compliance within Research and Development and is responsible for ensuring the programs have the correct understanding and knowledge of the requirements necessary to deliver a compliant Design History File and associated programme documentation. This roles has responsibility for managing a team of Design Compliance Facilitators who will ensure, via inspection and audit of documentation and records, that the output from all programs run within the company or outsourced to external contract development are appropriate, complete and meet Quality System and Regulatory standards requirements. This role is responsible for identifying any discrepancies and addressing them through appropriate channels. This role is responsible for working with the Quality System Coordinator and Programme Director to develop electronic solutions to maintain design history files in appropriate electronic and paper based formats. The role holder will lead any department specific corrective, preventive or improvement projects.
Reporting Structure This position reports to the Business Process Director. Performance Objectives Within the first month: Technical Expertise and Leadership within Design Controls which includes performance management of the Design Control Facilitators. Manage design stage gate audits of each project ensuring that compliance status/risks are fully understood and communicated at each design stage gate review Lead the Design and Development Risk Management activities, deliver training to all relevant D&D staff on risk management methods and chair all D&D Risk Management Review Boards. Responsible for oversight and timely completion of actions arising from RMB meetings. Lead auditor within the QMS Internal Audit programme | 
