Product Quality Lead, based in Gothenburg, Sweden or Macclesfield, UK.
Take the responsibility to ensure our pipeline becomes a reality!
Join us in Development Quality and take the lead in ensuring the hard work from the rest of the business is realised, as we optimally get every medicine out to patients without challenge. We never give up in diligently ensuring our patients receive quality and safe medicines, responding to a large variety of, often complex, demands.
We are a team of ambitious people, who want to go far and we’re all here to achieve. Backed by a science-led approach, we follow evidence to reach outcomes that benefit patients and AstraZeneca. It’s an inclusive and friendly community here – we share knowledge and ways of working. Here each voice matters!
The Product Quality Lead (PQL) role is a key source of Quality advice to the Product Development and Quality organisations. You would join a team of Product Quality professionals to ensure that Quality is built into our products and processes right through the Development Quality value chain to commercialization. The role involves interpreting external regulatory requirements and expectations into appropriate quality standards and ensuring their application by providing direction to the relevant organisations.
They PQL represents Development Quality on the CMC project teams as the “Voice of Quality” ensuring intrinsic quality is built into our portfolio of products and is the primary point of contact for technical product quality advice from Development Quality.
What you’ll do
In this role you will develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to the development and supply of drug products. You will also maintain an in-depth knowledge of the technologies and products and keep current with scientific changes and direction.
You will ensure internal standards and processes impacting Product Quality meet external expectation and are enabled to support any change in technologies and products. You will facilitate the implementation and interpretation in aspects of the Pharmaceutical Quality System within your project portfolio.
You will be accountable for the strategic Product Quality input into pharmaceutical project teams including technology transfer to Operations and contractors, and commercialisation. This will include an expertise in the products being supported and keeping up to date with related science and technology to ensure proactive and risk based intrinsic as well as extrinsic Quality is built into the product.
- Relevant scientific degree with extensive experience of working within a pharmaceutical GMP Environment.
- Working experience of drug development within a pharmaceutical development organisation.
- A broad and comprehensive understanding of Regulatory and Quality standards and Systems relating to the drug development process and experience of their application.
- A comprehensive understanding of the pharmaceutical/drug development process.
- Understanding of Project Management and Pharmaceutical Supply Chain processes.
- Ability to make educated and inspiring decisions in complex situations.
- Excellent team working, influencing and networking skills.
- Demonstrates independent judgement and uses risk management in complex situations.
- Capable of making decisions, acting courageously and communicating with conviction and inspiration.
- Demands excellence (sets high bar) and delivers.
- A good communicator with experience of interacting effectively across interfaces.
- Builds excellent relationships both internally and with external suppliers or service providers.
- Demonstrates drive and energy in the role to make a difference.
- Demonstrates a high degree of personal credibility.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace, and challenge perceptions. That’s why we work, on average, a minimum of five days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
This role is open from 30th November 2023 and we encourage your application no later than 8th January 2024.
Where can I find out more?
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.