Overview

Reference Number: JO-2109-475707
Head of Quality
Rate: Negotiable
Job Type: Permanent
Location: Salisbury

JOB SUMMARY

Reporting to the Director of Quality, the Head of QA will assist in the delivery of autonomous and innovative leadership to achieve:

  • Delivery of compliant Quality Systems, and development of a world-class QMS, through effective leadership of the QMS and Compliance teams;
  • Effective and swift development of health interventions, and increase the Companys competitive edge in translational research;
  • Delivery of a leading, discrete, and complex business, to meet the needs of the Companys ongoing future strategy;
  • Further enhancement of the Companys good reputation with all relevant stakeholders and sectors;
  • Reduction in regulatory obstacles through application of new technologies and an effective and motivated workforce;
  • Improvement of current levels of grant and other income;
  • Delivery of the strategic direction, and business objectives, of the Company;
  • Taking full responsibility of Quality Systems (including GxP).
  • Communication and key working relationships

Internal

  • Scientific and management of colleagues throughout company.

External

  • National and international scientific experts, academic institutions, private and public sector customers.

MAIN DUTIES AND RESPONSIBILITIES

  • Lead the QMS & Compliance teams to deliver compliant Quality systems, and develop a world-class QMS;
  • Provide operational direction and leadership to a large team of GMP Quality professionals, Documentation control, & Archivist staff;
  • Develop and manage the QA, GMP, & QMS programmes, policies, standards, and procedures to ensure conformance to the highest standards and regulatory agency requirements (MHRA, EU, FDA etc.);
  • Establish processes and systems that support collaboration, compliance and are simple and effective;
  • Lead and support where required with regulatory inspections;
  • Further develop, implement and manage processes that align with, and drive, effective systems for change control, deviations and investigations, complaints, recalls, risk management and CAPA;
  • Oversee GMP Quality system performance metrics, analyse compliance data and coordinate the necessary Quality reporting and escalation responses;
  • Manage the processes for the Quality Management Review Board, Change Control Review Board and Risk Management forums;
  • Provide expertise and guidance to senior management in the interpretation of global GMP regulations, ICH guidelines and internal policies and procedures;
  • Promote continuous improvements in quality systems and department infrastructure; assist with creation/revision of appropriate SOPs, Code of Practices, Policies & Key Quality documents;
  • Train, manage, and mentor QMS, GMP, & QA staff for the effective performance in cGMP processes & compliance activities.
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