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Ref: 882499 - Interim Director of Quality

09 May 2018

Our Life Sciences Client based in central London is recruiting for an Interim Director of Quality to have full oversight of all Quality activities ensuring compliance with all requirements of GDP and GMP and all applicable regulations, for a 6 month contract.

Role purpose:
  • Primary point of contact between the client and the GMP and GDP contract providers for all Quality matters and to provide strategic direction to the provider
  • Ensure an appropriate QMS is created, implemented and maintained, based on change and risk management principles, across the product lifecycle including pharmaceutical development, technology transfer, commercial manufacture and distribution, post marketing and product discontinuation
  • Ensure availability of appropriate resource to ensure all Quality responsibilities can be fulfilled
  • Reviewing and approving the Quality manual, Global Policies and any policy/instruction exemption request
  • Ensuring timely and effective communication, escalation and action for product quality and QMS failure
  • Conducting Management Reviews
  • Ensure effective partnership with other areas in the Company including Supply Chain, Regulatory Affairs and IT
  • Ensure marketed products meet registration, GxP and Regulatory Authority requirements
  • Ensure Quality objectives and performance indicators are in place, monitored and appropriate actions taken as required
  • Responsibility for overall Quality budget.

Requirements include:
  • Strong experience of pharmaceutical drug Quality Assurance experience with experience in a management/leadership capacity
  • Ideally a BSc/BA in Chemistry, Biochemistry, or a relevant science
  • Excellent GDP and GMP knowledge
  • Experience of Quality Systems appropriate for both Clinical Development and Commercial Drug Product
  • Knowledge of PV and Medical Information systems
  • Knowledge of applicable CFR, ICH, EU, and GxP regulations.

Keywords: Interim, 6-month contract, GMP, GDP, Quality Director, central London, Quality, Quality Assurance

Location: Central London – 4-5 days per week (at least 3 days onsite)
Duration: 6 months

To register your interest in this opportunity please forward an up-to-date CV to resourcing@pir-resourcing.com or contact Jo on 01480 499580, quoting reference 882499 and advising current availability and anticipated day rate.