Head of Quality

Macclesfield

Competitive salary and benefits offered

Pioneer a ‘new’ Quality way

As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trailing the latest models and technologies to improve reliability and excellence in our processes.

What we do is important and valued – we make a real-life difference to patients. Here we have built an unrivalled reputation in Quality, through our ‘Total Quality’ culture that takes us beyond pure compliance.

We now have an exciting opportunity for a Head of Quality UK Operations on our Macclesfield campus. At 100 acres Macclesfield is AstraZeneca’s largest UK campus with a variety of work environments including laboratories, factories and offices. We are currently undergoing an ambitious campus redevelopment driven by AstraZeneca’s pipeline.

The largest pharmaceutical site in the UK, we work closely with government and MHRA through various organizations like ABPI for the pharmaceutical industry in the UK on regulatory policy and legislative changes.

What you’ll do:

Motivating, leading and developing a quality team of over 200 employees you’ll make sure roles, responsibilities and reporting lines are clearly defined throughout the UK Quality organisation to assure a functionally independent quality unit, while at the same time being a strong and collaborative member of cross functional teams.

You’ll make sure that appropriate Quality standards are applied to the products and to the Macclesfield site operations and supply chain processes in accordance with regulatory requirements and AZ company standards. This will include ensuring compliance with regulations in the company’s market territories including inspection readiness at all times.

Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and ongoing professional development to maintain proficiency.

You’ll ensure the suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through participation in management reviews and through advocating continual improvement.

You’ll ensure systems are in place which support compliant disposition of Finished Products, API’s, Raw Materials and Components.

You will be instrumental in leading the Quality strategy for UK Operations and ensuring its successful implementation. In this leadership role you will also contribute to the Macclesfield campus strategic development as part of the Site Operations Leadership Team (OLT).

We’ll expect you to establish Quality & Compliance objectives and key performance indicators for the site which drives continuous improvement. This will also involve promoting a culture of continuous improvement through the systemic deployment of lean and six sigma techniques.

Our Macclesfield campus is additionally a key site for launching new products and as Head of Quality you will interface across departments to support and lead improvement projects to deliver more drugs, to more patients, more quickly and more efficiently.

Essential Criteria:

  • With proven pharmaceuticals experience you will ideally meet the requirements for an EU Qualified Person.
  • Qualified to a good degree level in a scientific subject area
  • Substantial industry experience in a site(s) producing pharmaceutical products under EU and US standards including aseptic and solid dose operations.
  • A consistent record of dealing with FDA, MHRA, EMEA and other regulatory agencies.
  • A strong leader who can evidence developing highly effective teams including leading through change.
  • Experience of working cross functionally and internationally.
  • Broad understanding of supply chains and the concepts of Manufacturing Excellence/Lean manufacturing.
  • Ability to deal with complexity and uncertainty.

Be the voice of the patient

Interested in this unique opportunity? Apply today! We welcome applications from 23/07/2021 to 13/08/2021

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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