Clinical Quality Manager/ Senior Quality Manager (Level is flexible based on experience)
Hertfordshire – 25% travel to sites globally
Impressive basic and package
Our client is is a leading, global pharmaceutical company who are looking to add a Clinical Quality Manager to oversee their clinical trials, systems and CROs, leading audits and health authority inspections. This position will require travelling globally to support with on site preparation and audits.
Key responsibilities;
- Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence
- Support and conduct Clinical Investigator Site Audits, Vendor audits and others
- Support and conduct Pre-inspection Readiness Visits
- Support management of Health Authority Inspections
- Support CAPA Management
- Compile and analyze audit metrics to communicate trends to business stakeholders
- Provide GCP guidance to clinical trial sites and clinical study team members
Requirements;
- Previous Quality experience within GCP
- Audit preparation, audits and inspections
- Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials
- Flexibility towards working days/ hours as may require some out of hour meetings with clients
For more information, please apply below or email a copy of your CV to kellie.saul@cpl.com
- Agency: Cpl Life Sciences
- Reference: JO-2307-519549
Website: Cpl Life Sciences
- Posted: 1st September 2023
- Expires: 29th September 2023
