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Job Details

**GCP/PV Compliance Manager/Senior Manager - South East UK**

Company: Advanced Clinical Recruitment Ltd
Location: Cambridge Area
Reference: QA-GCP-PV
Closing Date: 23 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary + Package

Job Summary:

I am currently representing a very interesting and exciting Global Biopharmaceutical company who are looking to add a GCP/PV Manager to the expanding Quality group. The company have a very strong presence Worldwide and they have an incredibly strong reputation too! The GCP/PV Manager will have both hands-on audit responsibility and also oversight responsibility in relation to the Audit and Inspection programs. They will also with Senior professionals within the group.


Job Description

This is an exciting opportunity for a Compliance Senior Manager (Auditor) position within the Global Research and Development Compliance and Audit team. It is a key Quality Assurance role in the organization, with primary responsibility for planning and participating in global GCP and PV audits. The breadth of audits performed include audits of the clinical trials, vendors, internal processes and pharmacovigilance activities.

The position requires approximately 30% travel to international audit Sites, and also supports regulatory inspections of clinical sites and company facilities. 

Key Responsibilities:

  • Plan, conduct and report routine and directed clinical trial, GLP and PV compliance audits 
  • Identify and communicate compliance risks to management 
  • Host and/or play a lead role in regulatory authority inspections 
  • Lead process improvement initiatives 
  • Author and contribute to the development of cross functional controlled documents 

Basic Qualifications:

  • Bachelor ’ s degree in related discipline 

Preferred Qualifications:

  • Auditing experience in GCP and/or PV auditing 
  • Experience supporting regulatory authority inspections 
  • International auditing experience 
  • Participation in process improvement initiatives 
  • Knowledge of regulations applicable to area of technical expertise 
  • Knowledge of clinical development and PV process and operations 
  • Knowledge of audit/compliance program design and audit methodology 
  • Knowledge of PV and GCP Quality regs, and ideally GLP


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, Manager, GCP Manager, London, Remote, Flexible, Central, PV, PVG, GvP

Apply for this job: **GCP/PV Compliance Manager/Senior Manager - South East UK**

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
S11 8NX
Tel:  0114 270 1741
Website:  Visit Our Web Site

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