Senior Manager, Quality Operations (External)

This is what you will do: 

The Senior Manager for Quality Operations will be responsible for leading and providing oversight of quality activities associated with drug substance/drug product technical transfer processes at contract manufacturing organizations (CMOs). The Senior Manager drives the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of Contract Manufacturing oversight, ensuring compliance with GMP in the supply of commercial and clinical product. Provide Quality service and guidance to various stakeholders. Execute strategies to control, and improve quality partnering with peers and influencing stakeholders to successfully embed a strong Quality culture. Identify, evaluate, and drive the remediation of quality risks and quality issues in collaboration with peers in Alexion’s portfolio. 

You will be responsible to: 

This position will report to Director of Quality Operations. Duties included but not limited to: 

• Managing Quality Assurance team responsible for providing oversight of quality activities associated with drug substance/drug product and tech transfer manufacturing processes associated with contract manufacturing organizations. Ensuring batches manufactured at contract organizations are released to cGMP and Alexion requirements.   

• Ensuring compliance of all contract organisations to both internal Alexion and country specific regulations. 

• Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements. 

• Provide quality and compliance guidance on all critical and major quality matters managed by Alexion/AZ. 

• Trending and analyzing quality aspects of technical transfer activities to measure key performance indicators, identify areas for continuous process improvements and risk mitigation, and propose and lead team implementation of appropriate CAPA. 

• Provide Quality oversight, input into quality documents e.g. QAGs, customer complaints as required.  

• Author, review and approval of Quality Agreements (QAGs), ensuring Quality Agreements are maintained with all GxP vendors. 

• Creates an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective. 

• Ability to apply lean approach to identify