GCP QA Manager

A leading clinical-stage biopharmaceutical company that focuses on cancer therapy is recruiting a GCP QA Manager. The organisation specialises in developing medicines that seek to block tumour immune evasion and offers patients benefits that are far more advanced than current immuno-oncology treatments. This is an exciting opportunity to join this organisation in either their UK based office or from a home-based capacity.

Job Responsibilities:

• Providing expert Good Clinical Practice (GCP) advice and working closely with functional groups to address compliance and quality assurance trends across our early phase oncology trials, many of which are first in class therapies.
• Setting priorities for QA activities, planning and conducting audits for Drug Development, as well as at clinical sites and laboratories.
• Having overall responsibility for the Quality Management System.
• Leading the directorate through regulatory inspections and co-ordinate non-functional training.

Skills and Requirements:

• Extensive experience in a QA function, preferably in the pharmaceutical industry.
• Excellent knowledge of ICH GCP & Clinical Trials Regulation.
• Oncology experience would be desirable, in especially early phase trials.
• Ability to give measured and expert advice and manage complex and sensitive QA data.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Josh Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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