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Company name : AstraZeneca
Location : Wilmington, DE 19850
Position : Quality Manager – Vaccine Operational Team
At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of Organisation to reset expectations of what a pharmaceutical company can be. This means we’re opening up new ways to work, pioneering innovating methods and bringing unexpected teams together.
Make a meaningful impact on people’s lives with life-changing medicines!
Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society!
The Quality Manager (QM) is accountable for the Quality management of assigned Quality system and compliance activities for GSQ supply chains and suppliers.
You’ll be responsible for all Quality activities that directly support execution of assigned Quality Management System elements. You will be assigned key areas of responsibility, but will be expected to learn other areas of the quality system to help support the rest of the team during times of peak workload or holiday coverage.
What you’ll do
Complaints Management – Coordinate complaints issued for GSQ as a supplying site or coordinating site
Support GSQ Quality Management Systems
Facilitate process and system improvements
Support audits and inspection requests for sites
Product Release – Assign Usage Decision for Formulated and Packaged products (in accordance with Manufacturing License), Active Pharmaceutical Ingredients, Starting Materials and Medical Devices.
As assigned, serve as Business Process Owner(s) or Deputy BPO for the governance of the following systems: Complaints Management and Stability Management.
Essential for the role
Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering (Note: there may be specific additional requirements depending on the regulations in each country). Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
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 travel nationally and internationally as required approximately 10% of your time.
Desirable for the role
Experience working in a PCO/PET organization or Lean/Six Sigma training.
Multi-site / multi-functional experience
Proven experience in Quality Assurance or combination of Quality and Technical
Masters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field
Make an impact, here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.
Be empowered to be innovative and creative where difference is valued
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development
We welcome your application no later than 12th August 2022
Where can I find out more?
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