Director, Strategic Advice

at  Alexion PharmaceuticalsInc

GENERAL ACCOUNTABILITIES

• Ensuring own tasks are performed to current practices and in accordance with company policies, standards, SOPs, and guidelines
• Promoting a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
• Communicating effectively with QA colleagues and business stakeholders
• Maintaining knowledge of relevant industry information affecting quality and compliance arena
• Leading training for colleagues and business stakeholders as required.
• Involved in and may lead the development and/or revision of QA processes, projects, and tools
• Coaching and mentoring QA colleagues

THIS IS WHAT YOU WILL DO:

As the independent second line R&D quality assurance function for our mission is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.
The job holder is responsible for managing business relationships with defined stakeholder groups and senior leaders in R&D and for the strategic development and delivery of a GXP risk-based robust quality assurance program and quality management activities for these stakeholders. Additionally, the job holder is responsible for delivery of proactive end‐to‐end GXP inspection support and management.