Due to recent growth and acquisition we have multiple opportunities within QA working with suppliers, colleagues and customers across many countries and interacting cross-functionally with supply chain, supplier relationship, technical and project roles. 

GES QA are a part of Operations Quality. We are embedded into and support Global External Sourcing (GES). GES QA are responsible for the Quality Assurance management of AstraZeneca's External suppliers, which include Finished and Packaged Drug Products, Semi-finished Products, Active Pharmaceutical Ingredients, Intermediates, Registered Starting Materials, packaging material, devices, process chemicals and excipients. We are a diverse organization with staff located globally.

Due to an increasing product range there are multiple role vacancies in the Europe Middle East and Africa (EMEA) QA team. This team manage the quality aspects of a external formulation, packing, API and API starting material/intermediate suppliers based in the EMEA region (~90 suppliers). The role holder will manage a portfolio of suppliers, a range of technologies are available based on experience and development needs e.g. sterile manufacture, tablets, API, packing. The role holder will work closely with GES Supplier Relationship Managers, supply chain professionals and other external sourcing professionals as part of the GES ways of working.

These roles can be based from: UK - Alderley/Bristol, Sweden - Sodertajle, France - Dunkerque, Germany - Hamburg or Italy - Milan



The main accountabilities include:
•  Assuring the quality of material received by AstraZeneca from their portfolio of suppliers through applying GES supplier management processes. This includes, Quality System oversight, product quality complaint and deviation investigations, quality issue management and escalation, product release, QA Agreements. 
•  Driving quality improvements at their suppliers as part of a cross functional team
•  Managing the quality aspects of major changes at the suppliers, including technical improvements, regulatory interactions, inspection support, site transfers.
•  Improving GES QA processes and ways of working to drive efficiency.

Some travel is required. There is a high level of independence in the role.

Essential:

• Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering. 
• Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role 
• Excellent oral and written communication skills
• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc. 
• Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)
• Strong problem solving skills
• Strong negotiating/influencing skills
• Ability to work independently under his/her own initiative. 
• Ability to travel nationally and internationally as required up to approximately 20% of their time. 

Desirable:

Manufacturing site experience 
Proven experience in Quality Assurance or combination of Quality and Technical 
Masters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field
Experience working in a PCO/PET organization or Lean/Six Sigma training.