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.

The Global Supplier Quality (GSQ) organisation leads Supplier Quality oversight for externally sourced materials to ensure that they align with the AstraZeneca Quality Standard, are safe and effective and meet the required regulatory standards. We do this through execution of the key Pharmaceutical Quality System (PQS) and supplier management business processes, by experienced and qualified Quality Professionals.

This is a diverse and exciting role working with Suppliers, Contractors and a broad range of AstraZeneca sites and functions. You will collaborate with colleagues and customers across many countries and interact cross-functionally with supply chain, supplier relationship, technical and project roles. Some travel may be required along with high level of independence for the role. The role can be placed both in Södertälje (Sweden) or Macclesfield (UK).

Key accountabilities

GSQ provides Quality oversight globally for approximately 1,600 supplier sites in AstraZeneca Operations. The scope of the organization includes outsourced API, Biologics CMOs, Direct Materials including Devices, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.

In this role, you will be responsible for assuring the quality of materials received by AstraZeneca from the designated supplier portfolio and will proactively ensure GMP and regulatory compliance during supplier related projects. The role includes the responsibility for the Quality System oversight of Supplier related product quality complaints, change controls, deviation investigations, issue management, and Quality Agreements between AstraZeneca and External Suppliers; and the preparation and submission of Supplier Quality Risk Assessments, and support to Regulatory Agency inspections of supplier sites and site transfers. You will drive quality improvements at the supplier as part of a cross functional team.

Your role will also include the quality review and approval of Chemistry and Manufacturing Control (CMC) documents associated with changes or product establishment at suppliers. Key to this role will be maintaining an understanding of relevant production processes and quality systems.

Essential skills:

• Degree in a science / technical field such as Pharmacy, Biology, Chemistry, Engineering or equivalent experience
• Broad experience with a minimum of 5 years relevant work experience in either the pharmaceutical operations environment or a pharmaceutical Quality Assurance role
• Excellent oral and written communication skills
• Strong proven knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also, strong understanding of industry standards such as Pharmacopoeia, ISO standards, etc.
• Shown experience working cross-functionally and leading significant improvement initiatives (e.g. project management skills)
• Strong problem-solving skills
• Strong negotiating/influencing skills
• Ability to work independently under your own initiative
• Ability to travel nationally and internationally as required, up to approximately 10% of their time

Desirable skills:

• Experience working in a PCO/PET organization or Lean/Six Sigma training
• Multi-site / multi-functional experience - particularly within a manufacturing site environment
• Shown experience in Quality Assurance or combination of Quality and Technical

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together.

Are you ready to bring new ideas and fresh thinking to the table? Excellent! We have one seat available, and we hope it’s yours!

For further information regarding the role, please contact Malin Robin, tel +46 (0)8 552 510 54. Welcome with your application no later than September 1, 2020. Applications will be reviewed continuously.

Date Posted

Closing Date

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.