Site Quality Director - Development Quality, Global Quality Operations

This is an exciting opportunity for a senior quality leader who is motivated by combining strategic influence with operational leadership to drive quality excellence at scale!

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. In our dynamic environment, be supported by the brightest minds working together side by side.

Join us in Development Quality, a global function accountable for GMP Quality oversight across AstraZeneca’s Pharmaceutical Technology & Development (PT&D) and Pharmaceutical Sciences organisations.

You will play a pivotal role in maintaining the License to Operate across the Development functions and ensuring that Good Manufacturing Practice (GMP) standards are upheld to safeguard patient safety throughout the AstraZeneca project portfolio.

The role is placed at our dynamic R&D site in Gothenburg.

Your role

You are a Quality Leader with deep subject matter expertise and broad business experience, leading your team and drive a strong culture of quality, compliance, and continuous improvement.

You will provide line management to the local Quality team, fostering individual growth and team effectiveness to build a high performing, engaged, and collaborative organisation.

You will be a trusted leader who can connect strategy with execution, build strong stakeholder relationships, and create impact across a complex and evolving environment.

You will lead significant local cross-functional and global compliance initiatives, working collaboratively across Quality Assurance and line functions to influence ways of working and deliver meaningful compliance improvements.

As a member of the Development Quality Leadership Team, you will also contribute to the development and delivery of the Quality Strategy, supporting the Development organisation as well as the wider Operations business.

You will play a key leadership role in shaping and strengthening quality across the organisation.

Accountabilities/Responsibilities

• Accountable for ensuring that the site maintains the appropriate authorisations to carry out the GMP activities required by the business, and for assuring that the site meets the requirements defined in that authorisation.

• Ensure sufficient resource/capability to support the delivery of GMP activities from the site, considering current needs and anticipating strategic changes to future requirements.

• Owner of selected business processes, leading continual improvement of these processes ensuring effectiveness, compliance with relevant GMP regulations, and business efficiency.

• Working closely with partnering business functions and leadership to set strategic direction for quality within that area, maintaining quality oversight and assurance of appropriate standards, and driving continuous improvement.

• Working collaboratively with other Quality Leaders to drive harmonisation and standardisation of processes across the network of sites, removing barriers to work moving seamlessly between sites, and ensuring best practice is applied.

• Ensure appropriate Quality input to major Site Quality business improvement projects and may lead projects across the Development functions.

• Accountable for the ongoing Quality operational oversight of internal manufacturing at the site, assuring the quality of supplies and performance and responsible for product & material release decisions.

• Lead preparations in Development Quality to assure the integrity of data and readiness for regulatory authority inspections, including PAI.

• Drives, role models and supports a strong lean culture that promotes standardisation, simplification, and continuous improvement.

• Acting as an escalation point for complex issues, managing issues through to resolution.

Essential Requirements – Education and Experience

• Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry.

• Extensive experience within Quality Assurance in the pharmaceutical industry.

• Proven people leadership experience, including line management and team development.

• Strong knowledge of GMP and relevant quality standards and regulatory expectations.

• Excellent stakeholder management skills and experience from change management initiatives.

• Demonstrated ability to work effectively across functions.

• Experience leading business improvement, compliance, or transformation initiatives across complex organisations.

• A broad and comprehensive understanding of Quality Systems.

• Fluent in English.
   

Desirable

• Cross-functional experience.

• Experience working in a global environment.

• A comprehensive understanding of the pharmaceutical/drug development process.

• Eligible Qualified Person.

• Experience supporting regulatory inspections, driving inspection readiness, and maintaining a strong focus on data integrity and compliance.

You are a credible and collaborative leader with a strong sense of accountability and integrity. You bring a proactive and improvement-focused mindset, are comfortable navigating ambiguity, and can balance strategic priorities with operational demands. You have the confidence to challenge constructively, the judgement to make sound decisions, and the leadership presence to inspire trust and drive results.

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.

There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society. 

Make a meaningful impact on people’s lives with life-changing medicines. 
Welcome with your application no later than May 24th 2026.

About AstraZeneca Gothenburg
Our stunning campus in Gothenburg is an incredibly vibrant and diverse place, with about 3,000 employees and a high proportion of international talent. Inclusion and diversity are embedded into everything we do, driving creativity and people empowered to innovate for patients by challenging conventional thinking. 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.

Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Date Posted

11-maj-2026

Closing Date

24-maj-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.