Job Description
Senior Specialist External Quality Key Accountabilities:
Ensure audit due dates for suppliers are maintained. Manage and provide guidance and/or assist in defining, implementing and follow-up for supplier audit reports and CAPA ensuring adequate corrective action is in place and monitoring the effectiveness of that action. Development of a Supplier Quality management performance evaluation through Key Performance Indicators (KPI) and continuous improvement for the highest effectiveness of the supplier management system. Contribute to the development, maintenance and improvements of supplier management policies, standards and procedures. Participate in supplier development projects and continuous improvement activities focusing on supplier quality. Assist in Internal audits and ISO/FDA audits. Responsible for SAP Quality Module implementation (QM Views, inspection plans, AMPL) Responsible for overseeing Supplier related changes and implementation of required actions to address changes. Responsible for tracking Supplier quality on a monthly / quarterly basis, identify supplier non-conformance trends and implement appropriate supplier actions. Communicate to management quality and regulatory issues on a timely basis. Assist with development of the Approved Supplier List and areas to be targeted during the assessment or evaluation. Identify and leverage best practices across supplier qualification, surveillance, process and quality management system audits. Essential Requirements:
Bachelor's Degree in Biology, Biochemistry, Chemistry, Engineering or related fields 1+ years of supplier quality experience 7+ years of Quality experience Computer Skills:
MS Outlook, MS Powerpoint, MS Excel, MS Word Desired Requirements:
Drug Substance and/or Drug Product experience Autologous, Allogenic, or In-vivo cell therapy experience Graduate degree in related field The annual base pay (or hourly rate of compensation) for this position ranges from $100,880 to $151,321. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 26-May-2026 Closing Date 08-Jun-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world's most serious diseases. But we are more than one of the world's leading pharmaceutical companies. 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. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We're curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We're driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you'll do work that has the potential to change your life and improve countless others. And, together with your team, you'll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
