Associate Director, GCP Quality Improvement Manager
A leading biopharmaceutical company is looking for an Associate Director, GCP Quality Improvement Manager to join their team in Uxbridge.
- Liase with GCP Compliance & Process Teams to proactively identify opportunities to streamline and strengthen GCP processes
- Serves as GCP SME when SOPs are written or revised
- Manage Quality Events and Actions (Process Deviations, CAPA) within regulated Quality Management System
- Represent GCP expertise on cross-functional teams for GCP related process improvements resulting from new/revised regulations or guidance
- Leads cross-functional rapid response teams for identified GCP process violations needing immediate remediation
- Work closely with Regulatory Intelligence team to identify changes in global regulations affecting current Regeneron processes as they relate to GCP
Skills and Requirements
- 5 years' experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function.
- Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
- Demonstrated Issue Management and CAPA experience in a clinical environment
- Demonstrated skills in taking initiative and working independently
- Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization
- Ability to effectively manage multiple priorities with a sense of urgency
- Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.