Director, Patient Services, Quality & Compliance

This is what you will do:

The Director Patient Services (PS) Quality and Compliance is a critical new role in the Patient Services team and is responsible for the overall Quality and Compliance of the Patient Support Programs and Services for patients on Alexion therapies. The Director will be responsible for leading the Quality team including setting strategic direction for the function partnering with internal and external stakeholders Patient services Operations to ensure minimal risk and effective mitigation strategies to ensure regulatory and business requirements are met. Additionally the Director will be responsible for leading the Patient Services Support Programs and Data Governance committee implement industry leading bestpractices by leveraging latest tools and technologies to gain efficiencies.

You will be responsible for:

• Responsible for ensuring that the PS quality processes and procedures meet regulatory requirements

• Lead Quality initiatives to ensure data integrity; periodic monitoring and oversight

• Assess and advise on the patient data governance activities & initiatives from a broader enterprise perspective

• Guide and advise on the key Patient data governance related decisions

• Recommend changes to policies standards and processes within patient data management

• Manage budgeting & resourcing for patient data initiatives and reviewing escalation requests

• Develop and evolve the PS quality assurance program ensuring program execution matches key Work Instructions

• Periodic monitoring review and manage changes to the Work Instructions to adjust to the changing business needs

• Ensure PS teams remain in compliance with key pharmacovigilance requirements through ensuring all employees and contractors have received required training that all employees/contractors are compliant with adverse event (AE) and product complaint reporting and that all remediation efforts are carried out per Work Instructions

• Implement critical tools and systems by automating repeatable tasks to improve efficiencies

• Work with Operations teams and other internal and external stakeholders to identify risks and areas for process improvement

• Oversee the execution and monitoring of internal and external audits

You will need to have:

• Bachelors degree in the Life Sciences or other relevant field

• 810 years of Patient Services experience primarily leading the Quality and Compliance patient safety functions

• Minumum 5 years of people management experience

• Proven ability working successfully in a fastpaced cross functional environment with many stakeholders that have competing interests

• Comfort working through uncertainty while managing multiple competing and frequently shifting priorities

• Working knowledge of legal regulatory and compliance rules within the biotech/pharmaceutical industry

• Ability to work with external vendors during the SOW PO and project budget accrual processes

• Strong fluency in English (written and spoken language)

• Strong knowledge of MS Office and ability to create and edit documents using Microsoft PowerPoint Excel and Word

• Ability to present to internal and external stakeholders of 2 to 100 people

• Ability to travel 30% of time including weekend travel

• The duties of this role are generally conducted in an office environment. As is typical of an officebased role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Experience working in patient services or HUBs in the rare disease industry supporting a patient services organization

• Strong passion for digital advancement and an innovative mindset

• Working knowledge of AI technologies and other bestinclass technology solutions