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 best-practices 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:

• Bachelor’s degree in the Life Sciences or other relevant field

• 8-10+ 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 fast-paced 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 office-based 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 non-linear 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 salesforce.com, AI technologies and other best-in-class technology solutions