Head of Quality - Global GxP Audit Programs

Location: Slough, England, United Kingdom
Salary: Bonus
Job Type: Permanent
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Head of Quality - Global GxP Audit Programs

I am currently in partnership with an exciting, growing Pharmaceutical company in Greater London (West) who are looking for a Head of Quality - Global GxP Audit Programs to join the team.

As Head of Quality, you will head up the company's Audit division to perform global group strategic planning and to manage the global team with the aim of standardising the audit program across regions.

The position is a strategic and tactical, hands-on leadership role providing for the oversight, planning, execution, and maintenance of the various GxP and REMS (Risk Evaluation and Mitigation Strategies) audit programmes, within R&D and Commercial environments.

Key Responsibilities:

  • Develops and leads the Global Quality GxP Audit Program Team to ensure roles and responsibilities are clearly aligned; development of personnel; establishment of succession planning; and, to ensure collaboration across all supported functions.
  • Maintains risk-based audit plans covering the Pharmaceutical Quality System (PQS) for commercial and R&D activities, and for internal and external processes and key service providers.
  • Generates and executes annual internal audit programme for GxP Functions, suppliers, pre-wholesalers, freight forwarders, and 3rd party service providers that fall under GxP Regulations in all territories
  • Generation of Key Quality Compliance indicators to give focus and drive actions at Area and Functional Lead level.
  • During audit lifecycle activities, ensure any potential quality incidents are identified and escalated to the appropriate function for action.

Key Requirements:

  • Bachelor of Science degree in a life science or engineering discipline. Post graduate degree is preferred.
  • Advanced knowledge of international drug product regulations. Broad experience within GxP disciplines (GPV, GCLP, cGMP) and REMS is preferred. Must have direct experience planning and executing a global auditing program.
  • Certification or formal qualification as an auditor within one or more of the GxP disciplines is desired.
  • Influencing skills in areas with no direct reporting authority

If this Head of Quality - Global GxP Audit Program looks as though it could be the challenge you seek, please get in touch as soon as possible, the role is live!

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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