Quality Director

Quality Director

Dunkerque, France

Competitive Salary & Benefits offered

Make a more meaningful impact to patients’ lives around the globe.

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

In Quality, our work is important and valued. An unrivalled forward-looking mindset, there’s no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products – discovery, development and commercialisation.

This is a unique opportunity to join our dynamic Dunkerque site as a Senior Leader and as the Quality Director and Qualified Person/Responsible Pharmacist on site.

Our pharmaceutical site in Dunkerque situated in the North of France, is involved in the production of inhalers for the treatment of Asthma & COPD. It is a strategic site within the AstraZeneca group, offering career opportunities in an international context.

Here we work together across the site, the region and the global teams to make an impact and find answers to challenges within Operations. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

As the Quality Director leading both the Quality Assurance and Quality Control organisations, we’ll expect you to ensure a functionally independent quality unit, while at the same time being strong and collaborative members of cross functional teams.

This will involve ensuring that appropriate Quality standards are applied to the products and to the Dunkerque site operations and supply chain processes in accordance with regulatory requirements and AZ company standards.

We’ll support you to define, manage and direct the quality department’s role on the AstraZeneca Dunkerque Production site (in terms of technical, communication, economic and human aspects) in accordance with the SHE, BPF(GMP), CGMP and organizational procedures in force on site. You’ll ensure compliance with quality regulatory requirements related to the products and site activities (Public Health Code, CGMP, GMP).

What you’ll do:

Manage communication with Corporate and Regulatory Agencies (eg ANSM – French National Agency for the Safety of Medicines and Health Products).

Ensure that there is a robust management review system in place, feeding through to the Quality Management System (QMS) for improvements and implementation.

Execute the strategic Quality Plan, ensuring Quality and Compliance objectives and key performance indicators are managed to drive continuous improvement.

Manage the financial budgeting cycle for the Quality Function in collaboration with Site Management, being accountable for meeting financial and productivity targets.

Recruit, motivate, lead and develop personnel with Quality, ensuring that personnel within the Quality Function align with relevant external and AZ Safety, Health & Environmental standards. This will guarantee the successful support from Quality to our customers and the supply chain objectives.

Essential Criteria:

  • A qualified pharmacist and Responsible Person (Quality Professional)
  • Proficient written and spoken English and French.
  • Qualified to degree/masters level in a scientific subject matter
  • Substantial industry experience in a site(s) producing pharmaceutical products under EU and US standards
  • A proven track record of dealing with FDA, ANSM and other regulatory agencies.
  • Experience of working cross functionally and internationally at a strategic level.
  • Broad understanding of supply chains and the concepts of Lean manufacturing (a lean qualification/belt would be beneficial). An Entrepreneur with Continuous Improvement attitude (Total Quality Management mentality) Coupled with a competitive edge to continuously drive efficiency.
  • Validated successful leadership experience along with evidence of developing highly effective teams.
  • Ability to deal with complexity and uncertainty.

Interested in this exciting opportunity? We’re waiting for your application, apply today!

We welcome applications from 02/07/2021 to 25/07/2021.

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