Quality Team Lead – Development Quality

Quality Team Lead – Development Quality

Macclesfield

Permanent opportunity

Competitive salary and benefits

Be the voice of the patient

Be proud to play a critical role as the eyes and ears of our patients. Unafraid of the responsibility, we monitor and sign off each batch as if the medicine were for our own family. All our contributions add up to improving the quality of patients’ healthcare and ultimate their quality of life.

We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes.

Business area

In the Clinical Supply Quality Team, we are responsible for quality in the development of new Clinical Trials and collaborations and the supply of Investigational Products to them. With a portfolio encompassing both small and large molecules, combination products and ground breaking technologies we are providing novel life-changing medicines to our patients around the globe.

We have an opportunity for a Team Leader in our Developmental Quality team!

What you’ll do

As Clinical Supply Quality Team Leader you will lead a team of Quality Advisors. You will work with supply chain teams and take responsibility for Development Quality release of externally manufactured Drug Substance, Drug Product and/or Investigational Medicinal Product for clinical trials.

The Team Lead works with Clinical Supply functions directly and through their team to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability.

Developing and maintaining knowledge of the quality regulations and guidelines applicable to the clinical supply chain is part of the role. Also, you will manage colleagues for enhanced individual and team performance, working with the Extended Leadership Team in Development Quality to develop and implement global objectives. You will support the Business Process Owner for release, applying lean principles and leading areas of continuous improvement to enhance Clinical Supply Quality and Development Quality processes.

Operating as part of a global organisation with an integrated approach to build an organisation with common processes and ways of working you will also:

  • Develop solutions to a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought, strategic vision and analysis

  • Lead the delivery of Quality activities for their assigned projects. Accountable for aligning all Quality activities across a project and empowered to resolve any project quality issues across Development Quality sections

  • Support Issue Management Teams on project specific issues

  • As a Development Quality Business Partner, work closely with the leadership of our Clinical Supply Chain to set strategic direction for quality within that area, maintaining quality oversight and assurance of appropriate standards, and driving continuous improvement

  • Drive, role models and support a strong lean culture that promotes standardisation, simplification and continuous improvement

  • Be responsible for the ongoing Quality operational oversight of pack/label CMOs to enhance the quality of supplies and performance

Essential for the role

  • A scientific degree with a number of years’ experience of working within a GMP environment, preferably within a pharmaceutical development organization is needed for this role.

  • A broad understanding of Quality Systems and GMP

  • A comprehensive understanding of the pharmaceutical/drug development process

  • Good knowledge and reputation in the QA arena and specifically in GMP matters

  • Understanding of Clinical Supply Chain processes

Why AstraZeneca…

It’s a place to grow a fulfilling and exciting career with constant opportunities resulting from new products, technologies and growing areas like biologics. Our continued growth gives you greater exposure than anywhere else.

So, what’s next…

Are you already imagining yourself joining our team? Great, because we can’t wait to hear from you!

We welcome your application no later than 10th November 2021

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