ProClinical is currently seeking a Senior PV Audit Manager for a global healthcare company based in the UK. The Senior PV Audit Manager will work in close collaboration with the Global and the Regional Lead of Global Quality Management.
- Select and manage qualified service providers for Global Quality, e.g., contract auditors
- Manage audits and contract auditors in line with the audit plan, business model and applicable SOPs
- Plan, supervise, conduct, and support internal and external GVP audits
- Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees
- Maintain tracking for audits, findings and corrective and preventive actions.
- Provide input for the development and maintenance of the audit tracking tool
- Coordinate the preparation for GVP inspections
- Coordinate the responses to Health Authorities
- Supervise and provide input to the corrective and preventive actions
- Follow-up on the development, implementation and completion of corrective and preventive actions with the inspected Functional Areas
- Maintain tracking for inspections, findings and corrective and preventive actions.
- Provide sound advice and interpretations related to current GVP guidelines and regulations to Senior Management and employee
- Be accountable for quality-related input in decision making processes with relevance for GVP compliance
- Act as quality liaison for assigned projects
- Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and 'lessons learned from audit/inspection'
- Foster a continuous improvement mentality within
- Ensure the establishment and maintenance of the required Quality Documentation
- Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution
- Manage planned and unplanned deviations reported by the Functional Areas and support them by resolving the deviations.
- Develop and support global compliance training procedures in collaboration with other affiliates and provide training in expertise as assigned.
Skills and Requirements:
- Educated to Degree level in a life sciences discipline
- Qualification as an auditor
- Several years of clinical/industry/health authority or otherwise relevant experience, including Quality Management for Pharmacovigilance and leading PV audits
- Expert knowledge/experience in relevant regulations and guidance documents, in the area of Pharmacovigilance.
- Excellent leadership skills and knowledge of working in a cross-cultural business environment
- Understanding of change management processes
- Well versed with MS Office
- Well versed with CAPA Management systems, Track wise preferred
- Very good communication skills (written and oral) in English
- Problem solving and resolution skills
- Analytical and creative thinking
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 call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.