GCP QA Manager

  • Salary: Around £65K
  • REF Number: 00050306
  • Consultant: Jim Gleeson
  • Contact: 01438 842973
  • Date Published: 01.04.2021
  • Sector: Non-Specific
  • Location: London, London
  • Discipline: Clinical Quality Assurance

Jim Gleeson is recruiting for a GCP QA Manager to join an innovative biotechnology company with a strong gene therapy pipeline in pre-clinical and clinical development as well as approved treatments. The role will be based at their London office, butwith some home working possible.

Salary:

Base around £65K with a good benefits package.

RESPONSIBILITIES:

As GCP QA Manager you will work closely with the GCP QA Director to provide Quality and Compliance support across all clinical research activities, internal and external.

Key duties will include:

  • Acting as Clinical Compliance Lead for assigned clinical trial programs
  • Leading development of relevant audit plans for assigned projects and manages audit plan execution
  • Managing and/or leading and following up GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors
  • Working closely with clinical study management teams to provide expert clinical compliance information, managing identified issues, and supporting continuous improvement
  • Evaluating, writing and/or reviewing operating procedures (e.g. SOPs), and performs other activities in support of an integrated cross-functional quality management system(QMS)
  • Assisting in inspection readiness preparation, and/or directly supporting regulatory agency inspection

QUALIFICATIONS:

As GCP QA Manager you will require:

  • A relevant life science degree
  • Industrially based (ideally biotech) experience of performing internal and external GCP audits
  • Experience of managing audit and CAPA management programmes
  • Very strong communication and interpersonal skils
  • Ability to travel up to 30%
  • Ideally have experience of working with advanced therapies

Apply:

Entitlement to work in the UK is essential. For more information please contact Jim Gleeson on 01438 842973 or email jgleeson@ckclinical.co.uk. Please quote reference 50306 in all correspondence.

CLINGEN

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