Head of QA (GCP & GVP), Hertfordshire

  • Salary: Competitive
  • REF Number: 00031516
  • Consultant: Jim Gleeson
  • Contact: 01438 842973
  • Date Published: 11.12.2014
  • Closed Date: 24.08.2015
  • Sector: Non-Specific
  • Location: South East
  • Discipline: Clinical Quality Assurance

Jim Gleeson at CK Clinical is recruiting for a permanent Head of Quality Assurance (GCP & GVP) with a successful and expanding Clinical Research Organisation, to be based at their offices north of London.

Responsibilities: As Head of Quality Assurance (GCP & GVP) your role will be to oversee the company's QA function with regard to all Clinical and Pharmacovigilance activities.

Key duties will include:

  • Developing and maintaining the Global PV and Clinical Trial Quality Assurance system
  • Developing, maintaining and executing the audit program to assess GVP and GCP processes internally and externally
  • Coordination of preparations for and hosting of audits by regulatory authorities and company clients
  • Provision of QA review, input to deviation investigations and ensuring CAPA follow-up
  • Management of the internal training system with respect to GVP, GCP and SOP/WI training

Qualifications:

As Head of Quality Assurance (GCP & GVP), you will require the following:- A relevant scientific degree

  • Very strong experience of Clinical and Pharmacovigilance Quality Assurance management, ideally gained within a CRO environment
  • A thorough understanding of the clinical trial process and ICH-GCP requirements
  • Excellent first hand auditing experience

For more information or to apply for this Head of Quality Assurance (GCP & GVP) position please contact Jim Gleeson on +44 (0)1438 842973 or email jgleeson@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL31516 in all correspondence.

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