Company: Advanced Clinical Recruitment Ltd
Closing Date: 11 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary & Corporate Package
I am currently working with a very interesting and exciting Global Biopharmaceutical company, who are looking for a Director of Clinical Quality and Compliance to join their team in Central London! The company work in multiple areas across the industry, and their products excel in each area. They are a very promising entity with a fantastic reputation both across Europe and the US. The Director will have over 10 years' expertise within Quality (GCP) and will ideal have leadership experience.
The Director Clinical Compliance provides guidance and leadership to the Clinical Development and Regulatory Affairs project and clinical study teams in the investigation, correction and prevention of potential GCP Compliance issues at investigator sites, CROs, and Clinical Development & Regulatory Affairs as they apply to Europe. Incumbent will lead the CDRA Inspection team for Sponsor/Monitor Inspections and assists in the preparation and conduct of Regulatory Inspections within CDRA, Investigator sites and with Business Partners, within Europe as applicable. Incumbent will be responsible for developing systematic approaches and trending to ensure best practices for the company, and high quality/efficient/risk mitigating processes within clinical development to assure GCP compliance is integrated into our processes with a focus on the end results.
• Lead/Facilitate Investigations of non-Compliance sites and vendors/CROs in Europe as part of escalation process with Clinical Team Leads, QAA and other team members as needed.
• Provides Clinical Compliance guidance and support for GCP and the EU Directives to Project and Clinical Study Teams in Europe during development (as needed) and for pivotal studies to assure inspection readiness and planning occurs throughout development lifecycle.
• Supports Head, CCT in the development of European inspection strategies and works with teams across CDRA in building-in “inspection readiness” during start-up, conduct and reporting in Europe.
• Lead the preparation of Sponsor/Monitor Regulatory Inspections with Clinical/Project teams, etc. partnering with Regulatory Affairs and Quality Assurance and Auditing and Business Partners as required for European based inspections. Support regulatory site inspections as needed including being the sponsor liaison for foreign site inspections in Europe
• Member of the CDRA inspection team for Regulatory Inspections in Europe (e.g. EMA, MHRA, BIMO)
• Analyse and evaluate root cause, develop and implement CAPAs and track action items to closure for cases of Suspected Serious Non-Compliance on project/study level activities from audits, inspections, escalations, quality control measures etc. in conjunction with CSTL and others as applicable in Europe.
• Facilitate with CDRA functional head(s) Process improvement initiatives as needed in Europe.
• Bachelors or Master’s degree with at least 10 years of relevant industry experience.
• 8-10 years’ experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.
• Excellent communication skills and ability to work with people in all levels of the organization and externally.
• Demonstrated skills in taking initiative and working independently
• Experience with FDA, EMA, MHRA and/or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
• Demonstrated experience in driving development of CAPA plans to address potential non-compliance.
• Experience running and implementing process improvement projects
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
+44 (0) 114 270 1741
LinkedIn Search: Sam Caley Quality Assurance
Keywords: QA, Quality Assurance, GCP, GxP, GMP, GLP, Good Clinical Practice, Auditor, Audit, GCP Audits, Clinical Quality Assurance, Lead Auditor, Head or Quality, Senior Auditor, Senior Manager, Management, Audit Strategy, Structure, Home Based, Field Based, Pharmaceutical, Jobs in Pharma, Pharmaceutics, Generics, Specials, CRO, CQA, GCP Auditor
Regus 2nd Floor
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