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Compliance Manager

Remote, Middlesex   •  £0 - £25.88 per hour  •  Contract/Temporary, Full time


CK Group are recruiting for a GCP Compliance Manager to join a biopharmaceutical company, who are based in Uxbridge on a contract basis for 12 months.

Rates:
Hourly: £25.88 PAYE or £34.77 Umbrella

Company:
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Location:
The role is remote based position but the office team location is Uxbridge. Ideally you should be able to travel into the office occasionally.
GCP Compliance Manager

  • To support compliance advice and oversight to the business for Good Clinical Practice (GCP) activities
  • Strengthen and advance the QMS
  • Improve R&D processes through contribution of expertise in identifying appropriate CAPAs
  • Enable timely completion of CAPAs through CAPA status reports
  • Identify CAPA trends

Responsibilities:

  • The role of the GXP Compliance Manager is to support the provision of proactive GCP compliance oversight and guidance to functional areas and stakeholder groups within the R&D organization. Activities are to be performed under supervision of Compliance Senior Manager and/or Director GCP Compliance.

Experience required:

  • Minimum 4 years in biopharmaceutical industry
  • Minimum 2 years in GCP compliance
  • Experience in exception management (include RCA) in a GCP setting
  • Experience supporting regulatory authority inspections of GCP (e.g.clinical research, pharmacovigilance) activities
  • Participation in process improvement initiatives

Knowledge:

  • Knowledge of global GCP regulations
  • Knowledge of regulatory authority inspection processes
  • General knowledge GCP processes and operations in the bio-pharmaceutical industry
  • Understanding of audit/compliance program design trials, or working on clinical trials at a biotech, pharmaceutical or CRO company

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54102 in all correspondence. 


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

  • Agency: CK Group
  • Reference: 54102
  • Posted: 26th July 2022
  • Expires: 23rd August 2022

CK Group

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