Director, Patient Services, Quality & Compliance

AstraZeneca • Boston, MA

2d • Hybrid

About The Position

Introduction to role: Are you ready to lead and innovate? As the Director of Patient Services Quality and Compliance, you'll play a pivotal role in ensuring the excellence of our Patient Support Programs for those on Alexion therapies. This is a new and critical position within our team, where you'll set strategic directions, collaborate with stakeholders, and implement ground breaking practices to meet regulatory and business requirements. Your leadership will drive the Patient Services Support Programs and Data Governance committee, leveraging the latest tools and technologies for efficiency. Are you prepared to make a difference? Accountabilities: 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 aligned 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

Requirements

• 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
• Minimum 5 years of people management experience
• Proven track record 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

Nice To Haves

• 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

Responsibilities

• 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 aligned 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

Benefits

• Annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role)
• Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees