Lead Quality Advisor, Clinical Supply Quality – Global Operations

Are you an experienced Quality Advisor feeling confident in leading in local and global setting and deliver through others? Then you could be the new colleague we are looking for!

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.

We now have an opportunity for a Lead Quality Advisor in our Clinical Supply Quality Team. The role is placed at our dynamic R&D site in Gothenburg.

In the Clinical Supply Quality team, we are responsible for quality in the development of 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.

Lead Quality Advisors in Clinical Supply Quality are responsible for providing high-quality leadership and leveraging digital solutions in a fast-paced environment to enable the delivery of novel and life-changing medicines to patients in all phases of clinical trials around the world.  Lead Quality Advisors work from set up of new supply chains and novel approaches to clinical supply delivery through to issue resolution for existing supply chains. To accomplish this, we expect you to feel confident in leading and have experience delivering through others. 

Your role
You are the prime source of quality/compliance advice to the Clinical Supply organization. You interpret external regulatory standards and expectations into appropriate quality standards. You provide mentorship to the Clinical Supply organization and Supply Chain teams to ensure overall compliance with AstraZeneca and regulatory requirements are met.

What you will do:

• Support Supply Chain design and set up for global clinical studies working with a variety of sources of investigational product

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

• Lead the delivery of Quality activities and inputs for innovation and improvement projects.

• Contribute to Supply Chain, cross-Quality and Clinical Supply Quality projects with expertise and delivery. This may include all Quality aspects of projects including IT projects.

• Support Clinical Supply functions in GMP inspections and input to GCP inspections where required

• Release of externally manufactured Drug Product and Investigational Medicinal Products and other routine activities required in the clinical supply chain

• Support quality events including major quality events involving supply chain issues

• Operate as part of a global organization with an integrated mindset to build an organization with common processes and ways of working.

• Drive, role model and support a strong lean culture that promotes standardization, simplification, and continuous improvement

Essential Requirements – Education and Experience Functional & Business Knowledge

• Science degree equivalent to a master's degree, with extensive experience of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organization.

• Experience in leading others in local and global setting and deliver through others.

• Experience in data integrity as a part of digital solutions, including implementation and risk assessment to ensure compliance.

• A broad and comprehensive 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.

• General excellent knowledge of quality assurance including good understanding of how to apply this knowledge to IT solutions and experience of IT tools.

• Understanding of Project Management and Supply Chain processes.

• Fluent in written and spoken English.
  

Skills and Capabilities

• Engagement, communication and stakeholder management skills, including presentation and influencing skills.

• Demands excellence (sets high bar) and delivers.

• Demonstrates independent judgement and uses risk management in complex situations.

• Demonstrates excellent quality leadership.

• Capable of making decisions and acting courageously.

• Excellent team working, networking skills and encouragement of team efficiency.

• A good communicator with experience of interacting effectively across interfaces with conviction and inspiration.

• 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.
  

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.

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

We look forward to your application no later than April 3, 2025.

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/

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 authorisation and employment eligibility verification requirements.