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GCP Quality Manager

Central London   •  Negotiable  •  Permanent, Full time

CPL are partnering with an exciting and reputable Pharma company based in London. We are looking for a GCP Quality Manager to provide guidance and leadership for preparation and conduct of company -sponsored clinical trials from the time of synopsis generation and protocol authoring through final CSR. This individual will create strategic partnerships and direct risk-based quality management activities with Clinical Study Teams. Furthermore, the position holder will be responsible for assuring that the Clinical Study Team and all relevant documents are inspection ready at all times. This is initially a 12 month contract role with strong potential of going permanent. This will offer up to £100K depending on experience.

Key Responsibilities:

  • Responsible for overseeing assigned clinical studies from a quality perspective within a program in conjunction with business and Director, QML
  • Lead Quality Risk Management activities on all company-sponsored clinical trials within assigned studies
  • Lead Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2
  • Reassess quality risks throughout the study and adjust the plan as necessary
  • Partner with Clinical Study Lead/Oversight Monitoring/CRO to monitor site level quality risks
  • Participate as an active Clinical Study Team (CST) member
  • Provide day to day quality and compliance support to CST members, including SSN/issue management (investigation/actions), audit responses, proactive quality management, CAPA oversight, protocol deviation review, audit/protocol deviation/issue trending
  • Interface with Director, GCP Quality Management Lead, to roll up study information and trends
  • Interface with GCP Quality Inspection Management Team to assure that studies within assigned program are inspection ready at all times, including conduct of quality assessments, participation in site inspection readiness visits, and participation in inspection conduct

Key Requirements:

  • Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant industry experience
  • 5+ years’ experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.
  • Excellent communication skills and ability to work with people in all levels of the organization and externally.
  • Demonstrated skills in taking initiative and working independently
  • Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
  • Demonstrated experience in driving Quality into the Clinical Trial Operations processes
  • Self-motivated with the ability to work effectively in a dynamic environment with ambiguity

  • Agency: Cpl Life Sciences
  • Contact: Joshua Aderinto
  • Reference: JO-2201-483572
  • Updated: 19th January 2022
  • Expires: 16th February 2022

Cpl Life Sciences

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