Join us as a Product Quality Lead in our Product Quality team! The Product Quality Lead (PQL) role is a key source of Quality advice to the Product Development and Quality organisations. You would join a global team of Product Quality professionals to ensure that Quality is built into our products and processes right through the Development Quality value chain to commercialisation. The role involves interpreting external regulatory requirements and expectations into appropriate quality standards and ensuring their application by providing direction to the relevant organisations.

The 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.

Development Quality is a Global group, with teams located in Gothenburg (Sweden), Macclesfield, (UK) and Durham (North Carolina, US). With a portfolio encompassing both small and large molecules, combination products and groundbreaking technologies you will be a part of providing novel life-changing medicines to our patients around the globe.

Your role
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. You will also provide Quality input into business, quality system and product development projects.

Preferred Requirements

Functional & Business knowledge

• 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.
  

You thrive when you work independently, when leading projects and take pride in structuring your day, knowing that the diverse workload can change the schedule with little notice. You are a problem solver who can look at solutions in a pragmatic way – coming up with creative solutions whilst still following our strict regulations.

Skills and Capabilities

• 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 effectively with conviction and inspiration across interfaces.
  
• Strong data-driven delivery and a continuous improvement mind-set.
  
• Builds excellent relationships both internally and externally.
  
• Demonstrates drive and energy in the role to make a difference and having a high degree of personal credibility.
  

Why Astra Zeneca
At Astra Zeneca, we take Quality seriously. Our work is important, valued, and at the forefront of discovery, development, and commercialisation. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and driven by our ambition to go far. We are a team of ambitious people who want to achieve. We work together as a team, get our pipeline out to patients sustainably, reliably, and safely. We follow evidence to reach outcomes that benefit patients and Astra Zeneca.

Make a difference! Apply now and join us in our journey to push the boundaries of science and make a real-life difference to patients. Welcome with your application no later than September 11, 2024.

About Astra Zeneca Gothenburg Hub
Our stunning campus in Gothenburg is one of Astra Zeneca’s three strategic science centers. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we’ve built a series of environments where innovation can happen.

Where can I find out more
Follow Astra Zeneca on Linked In https://www.linkedin.com/company/1603/
Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg: https://www.movetogothenburg.com/
Culture and atmosphere of the Gothenburg site: https://www.linkedin.com/feed/update/urn:li:activity:6496327311678410752/