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Compliance Senior Manager – GCP / PV Auditor

Surrey   •  Permanent, Full time


Jim Gleeson is recruiting for a Compliance Senior Manager ? GCP / PV Auditor to join a global biotechnology company. This will be a predominately home based position.
Salary: Around £80K plus good benefits

Currently all auditing being conducted remotely, pending easing of travel restrictions the role can entail up to 30% travel to international destinations
RESPONSIBILITIES:
As Compliance Senior Manager ? GCP / PV Auditor you will be planning and participating in global audits of Amgen?s clinical trials and pharmacovigilance activities. You may also support regulatory inspections of clinical sites and Amgen facilities.
Key duties will include:

  • Planning, executing and reporting routine and directed GCP and/or PV compliance audits internationally
  • Serving as a lead auditor for complex GCP and /or PV audit types
  • Identifying and communicating compliance risks to QA and R&D management
  • Hosting regulatory authority inspections
  • Contributing to QA process improvement initiatives
  • Authoring and contributing to the development of QA cross functional controlled documents

QUALIFICATIONS:
As Compliance Senior Manager ? GCP / PV Auditor you will require:

  • A relevant life science degree
  • Extensive international auditing conduct experience in GCP and Pharmacovigilance or as regulatory authority inspector
  • Experience of data mining, manipulation and data analytics would be advantageous
  • Experience supporting regulatory authority inspections
  • Participation in process improvement initiatives.

Apply:
Entitlement to work in the country you are based in is essential. For more information please contact Jim Gleeson on 01438 842973 or email jgleeson@ckclinical.co.uk. Please quote reference 51842 in all correspondence.


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Jim Gleeson
  • Phone: 01438 743 047
  • Reference: 51842
  • Posted: 6th October 2021
  • Expires: 3rd November 2021

CK Group

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