Successful Placement from PiR’s Interim Practice: Interim Director of Quality

Job Title: Interim Director of Quality

Client Profile:

Pharmaceutical company based in London with a portfolio of medicines that cover contraception, fertility, menopause, and osteoporosis. High growth ambitions creating a can-do culture requiring strong team work.

Role Requirements:

 

  • 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
  • Primary point of contact between the organisation and the GMP and GDP contract providers for all Quality matters and to provide strategic direction to the provider.
  • Ensure QTAs are in place with the service providers and appropriate oversight of the service providers including audit
  • Ensure availability of appropriate resource to ensure all Quality responsibilities can be fulfilled
  • Actively participate in the QMS by:
    • 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

Role Scope:

The role required somebody with a vast amount of experience of working as a Senior Quality Manager – able to manage people and systems, in a complex, pacey environment. In particular with extensive pharmaceutical drug QA experience, including in depth GDP and GMP knowledge and exposure to Quality Systems appropriate for both Clinical Development and Commercial Drug Product.

Outcome:

From a shortlist of two, the selected candidate offers extensive experience of managing Quality Operations in a fast paced and complex organisation. The candidate quickly demonstrated the value they could add in leading and mentoring the team and other stakeholders; embracing the exciting, innovative nature of the company.

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