Manager, Audits & Inspections
An exciting vacancy has arisen for a Manager in Audits & Inspections who will lead and participate in various types of GCP/GLP compliance for the development programs.
- Conduct/support GCP/GLP compliance audits of clinical investigator sites, service providers and internal system/process audits in accordance with the annual audit plan to determine compliance status and identify compliance risks
- Prepare audit reports and communicate audit findings to audit stakeholders as well as R&D Quality Management ensuring understanding of observations
- Collaborate with clinical compliance leads to identify audit needs and follow up post-audit activities to ensure appropriate implementation of CAPA, and monitoring successful completion of action items
- Assist in managing and training external auditors ensuring compliance with auditing standards and procedures
- Provide pertinent data to support quality and compliance metrics and trending
- Assist in the planning of clinical quality audit programs
- Develop and maintain study specific audit plans (SSAPs) and audit certificates
- Participate in strategic planning of organizational activities, as required.
- Participate in regulatory agency inspection activities pertinent to R&D
Skills and Requirements
- Minimum 5 years pharmaceutical or biotechnology industry experience in performing audits and participating in regulatory inspections
- GCP audit experience is required, GVP and GLP experience is valuable but not required
- Knowledge/understanding of the perspectives of regulatory agencies
- Bachelor's Degree in Business or Life sciences is required, advance degree is preferred
- Ability to manage multiple priorities simultaneously and work efficiently in a fast-paced culture
- Strong and clear understanding of Good Clinical Practices (GCP)
- Must be disciplined, detail orientated and excel in personal time management
- Collaborate and ability to interact all levels of the organization
- Excellent written and verbal communications skills
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