Overview

Reference Number: JO-2105-467754
GCP QA Manager
Rate: Negotiable
Job Type: Permanent
Location: Oxford

GCP QA Manager
Oxford

The role will work closely with the Director of Quality and staff to advise and oversee GCP compliance in the Clinical and Medical group in accordance with local and international quality requirements.The role will include review and approval of key quality documents, including SOPs, clinical protocols, key essential documents, and clinical study reports.

Key areas of responsibility will include, but are not limited to:

Supporting the Director of Quality in the management of the Quality Management System;

Ensuring good practices (GxP) are adopted and implemented throughout the organisation;

Providing Quality expertise and oversight internally to project teams and other departments;

Working with the Director of Quality to ensure the company maintains Inspection Ready Status at all times;

Acting in the capacity of Quality Representative for all tasks defined in the quality system documents;

Delivering Quality training to staff;

Auditing

Supporting the annual External/Contract Service Provider (CSP) audit programme;

Supporting the internal audit programme;

Managing the clinical audit programme;

Performing internal, CSP and clinical site audits;

Key Essential Document audits, including Investigators Brochure, Clinical Protocols and Clinical Study Reports;

Managing independent auditors.

Other Responsibilities of Role

Supporting and deputising for the Director of Quality (i.e., delegate);

Supporting the Director of Quality to ensure that the companys statutory and legal obligations are discharged to satisfy current legislation relating to Quality/GxP;

Ensuring compliance with GCP and other regulatory requirements.

Qualifications and/or experience required to perform the role

Minimum of four years quality assurance experience in a pharmaceutical or Biotechnology organisation;

At least two years experience as a Clinical Quality Assurance Associate/Auditor;

Degree in a scientific subject;

Experience of working in a small Biotechnology/pharma

Good communication and interpersonal skills with the ability to communicate effectively with staff at all levels and different cultures;

Good experience of auditing suppliers and clinical investigator sites;

Detailed knowledge of GCP is mandatory;

Knowledge of MHRA, EMA and FDA standards;

Knowledge of GCP for laboratories and GMP is desirable;

A good working knowledge of MS Office including Word, Excel, Outlook and PowerPoint;

A flexible can do attitude;

Ability to work independently;

Ability to interact with staff at all levels within the organisation and subcontractors.

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