Senior Specialist Development Quality

Do you have expertise in, and passion for, Quality & Compliance? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines? Then Clinical Supply Quality might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Clinical Supply Quality is responsible for compliance decisions that have an impact on AstraZeneca Clinical supplies and therefore AstraZeneca’s business and external reputation. Using risk management to evaluate compliance issues and to develop solutions, decisions are made against a background of regulations. These vary depending on the stage of development and against a set of standards that require interpretation.

We have an opportunity for a Senior Specialist Development Quality, in the Clinical Supply Quality Gothenburg team, who’ll be the prime source for quality & compliance advice and providing quality support to the science functions and throughout the drug development process chains. This is a great opportunity for you who are strong in quality and like to work close to new development drug projects, Good Manufacturing Practice and making sure quality is assured when delivering new products.  

What you’ll do

As a Senior Specialist Development Quality, you will work with supply chain teams and be responsible for Development Quality release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. When working with Clinical Supply functions, the Quality Advisor is expected 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.

You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you support.

Whilst taking on your own specialist areas and making good quality decisions, you will be encouraged to think strategically and to really set the direction. You will participate in lean projects and contribute to continuous improvement. This is a fantastic opportunity to get a good grounding in quality and to broaden your experience in investigational medicinal products and build your career in this field.

Operating as part of a global organization with an integrated approach to build an organization with common processes and ways of working you will also provide quality advice and input to:

• Support the development, implementation and continuous improvement of Good Manufacturing Practice (GMP) quality systems across the functions and support implementation of agreed global standards
• Support external activities for Packaging, Labelling & Distribution of Investigation Medicinal Product
• Investigate complaints associated with clinical products
• Provide quality input into the systems used by the Supply Chain e.g. Smart Supplies

In addition, you will provide support and guidance to satisfy external Regulatory Authority GMP inspections, provide appropriate Quality Assurance input to business improvement projects and support Issue Management Teams on specific issues.

Essential for the role

• Degree in pharmacy or similar science or engineering discipline with at least 3 years' experience working within a pharmaceutical GMP environment
• A broad and comprehensive understanding of Quality Systems and GMP is essential
• A comprehensive understanding of the pharmaceutical/drug development process
• Good communicator with experience of interacting effectively across interfaces
• Fluent in written and spoken English

Desirables for the role

• Good team working, networking skills and encouragement team efficiency
• Demonstrates independent judgement and uses risk management
• Capable of making decisions, acting courageously, and communicating with conviction and inspiration
• A good communicator with experience of interacting effectively across interfaces
• Builds good relationships both internally and with external suppliers or service providers
• Demonstrate a high degree of personal credibility
• Demonstrate drive and energy in the role to make a difference

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

Welcome with your application no later than 18th of August 2025.

About AstraZeneca Gothenburg Hub
Our stunning campus in Gothenburg is one of AstraZeneca’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 AstraZeneca on LinkedIn 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/

Date Posted

Closing Date