Director of Quality & Compliance – Patient Support Services Program

Position Overview  
The Director of Quality & Compliance will play a critical leadership role in ensuring the Patient Support Services Program adheres to all applicable regulatory, privacy, and quality requirements. This role will oversee internal compliance support requests, regulatory tracking, AI and data governance, contractual compliance, and quality assurance processes to maintain adherence to federal, state, and industry-specific regulations.  

The Director will play a critical leadership role in compliance operations, partnering with the Sr. Director of Quality and Compliance to drive strategic initiatives and ensuring continuity in decision-making when needed. The Director will serve as second-in-command, acting as the primary point of contact in their absence and providing strategic oversight for compliance operations. This role requires strong collaboration with internal and external stakeholders, including IQVIA Information Governance teams, product and tech operations teams, and compliance leads managing adverse events and training compliance.  

Key Responsibilities  

Regulatory Compliance & Process Management  
- Develop and manage a compliance tracking system to monitor evolving regulatory guidance from Boards of Pharmacy, Nursing Boards, Home Health Agencies, FDA, and other governing bodies.  
- Assess regulatory changes and implement process updates to ensure continuous compliance across patient support services.  
- Provide strategic guidance on regulatory compliance and operational implementation across all patient support programs.  
- Work closely with product and tech ops teams to operationalize compliant technology services and ensure adherence to regulatory and contractual requirements.  
- Oversee the development and execution of business continuity plans to mitigate compliance risks and maintain operational resilience.  

Data Privacy, AI Governance & Responsible Data Use  
- Lead efforts to ensure compliance with HIPAA, GDPR, and other global privacy laws, embedding data protection principles into patient support services.  
- Collaborate with IQVIA Information Governance teams to evaluate and approve AI use cases, data access requests, and data-sharing agreements.  
- Establish and enforce policies for responsible data use across patient support programs.  

Compliance Oversight & Team Leadership  
- Oversee the Compliance Leads Team, ensuring effective management of adverse events and training compliance in alignment with contractual obligations for clients and customers.  
- Provide leadership and strategic direction for contractual and operational compliance initiatives.  
- Serve as the primary point of contact for compliance-related inquiries in the absence of the Vice President of Compliance.  

Contract & Third-Party Compliance Management  
- Review and assess contracts, Statements of Work (SOWs), and third-party agreements to ensure compliance with regulatory and quality standards.  
- Facilitate Seats Use Agreements and manage third-party contracting efforts in collaboration with legal and procurement teams.  
- Partner with cross-functional teams to negotiate and define compliance expectations in external agreements.  

Quality Assurance & Operational Compliance  
- Establish and oversee quality assurance programs that ensure adherence to regulatory and contractual requirements.  
- Develop and implement compliance training and monitoring programs to strengthen organizational accountability.  
- Work closely with operations, product, and technology teams to integrate compliance principles into day-to-day business functions.  

Qualifications & Experience  
- 10+ years of experience in healthcare compliance, quality assurance, or regulatory affairs, with a strong background in patient support services, specialty pharmacy, or home health.  
- Proven leadership experience, with the ability to manage teams and act as a strategic advisor.  
- Deep expertise in Boards of Pharmacy, Nursing Boards, Home Health Agencies, FDA regulations, and global privacy laws (HIPAA, GDPR).  
- Strong background in AI governance, data privacy, and compliance approvals for emerging technologies.  
- Experience working with IQVIA Information Governance teams or similar data governance organizations.  
- Demonstrated ability to review and negotiate contracts, SOWs, and third-party agreements for regulatory compliance.  
- Knowledge of business continuity planning and risk management strategies.  
- Exceptional communication and stakeholder management skills, with experience working cross-functionally in highly regulated environments.  

Preferred Qualifications  
- Experience in pharmaceutical compliance, digital health, or