Senior Quality Supplier Manager - 12 Month Secondment / Fixed Term Contract / FTO

AstraZeneca ,
Macclesfield, Cheshire
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Senior Quality Supplier Manager - 12 Month Secondment / Fixed Term Contract / Fixed Term Opportunity Location: UK (Macclesfield) or Sweden (Gartuna) At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because an 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. 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. 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. The Senior Quality Supplier Manager (SQSM) 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 significant independence for the role. What you'll do 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. You will be accountable for the Quality System oversight of Supplier related product quality complaints, change controls, deviation investigations, issue management and escalation, 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. This 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 is building and maintaining a high level of 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 work experience, with relevant experience in either the pharmaceutical operations environment or a 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 Pharmacopoeia, ISO standards, etc. * Proven 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 the 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 * Proven experience in Quality Assurance or combination of Quality and Technical At AstraZeneca, we believe in the potential of our people and you'll develop beyond what you thought possible! We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. So, what's next! Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. Date Posted 04-Jun-2020 Closing Date 18-Jun-2020 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.

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