The **Senior Issue Lead**will be accountable for:
- ** Quality Events**: managing confirmed Major / Critical Quality Event (QE) cases through the investigation process including root cause analysis.
The Senior Issue Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case.
The Senior Issue Management Lead will direct the QE team in proposing appropriate Corrective and Preventative Actions and that completion of all those are evidenced in documentation as required.
The Senior Issue Lead will be assigned to and manage Critical and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team.
- ** Audits and Inspection Coordination**:Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation.
- Major are...