THIS IS WHAT YOU WILL DO:

Position Summary:
Alexion, AstraZeneca Rare Disease’s Central Quality Systems and Compliance (CQSC) unit is looking for an Associate Director of Quality Systems to join our team. CQSC partners with internal stakeholders across Alexion Quality, Commercial, IT, Operations and Supply Chain to deliver an effective & compliant quality system for drugs and devices.
In this role, the successful candidate will lead diverse quality systems initiatives with the objectives of evolving Alexion’s global quality management system and empowering our business partners to leverage quality as a strategic enabler.

YOU WILL BE RESPONSIBLE FOR:

• Lead implementation of value-added Quality Management System (QMS) improvements in collaboration with global stakeholders to achieve Alexion’s strategic Quality priorities.
• Sustain and improve QMS compliance in Change Control and other areas of assigned focus.
• Provide tactical and operational support to the Global Change Control Business Process Owner, including but not limited to, stakeholder management, process improvement execution, communication, technical writing and learning program development.
• Use deep process knowledge and experience to assist global business partners with the creation, review, approval, closure and monitoring of change controls.
• Identify, assess, communicate, manage, and mitigate quality system risks.
• Lead Change Control Review Boards (CCRBs) and drive CCRB improvement and standardization globally.
• Evaluate new or revised regulations for compliance gaps and support remediation efforts for gap closure.
• Represent CQSC function on business development and integration projects.
• Create and update procedural documentation and work instructions with accuracy and clarity.
• Support GMP and GDP audits and inspections.
• Liase with external consortia to keep abreast of industry trends and benchmarking.
• Creates and environment supportive of Alexion RDU’s Quality Culture and Values.