Program Quality Associate Director, Assurance

About this role

Job Description General Summary:

Vertex Patient Support (VPS) is seeking an experienced and highly motivated Associate Director, Assurance (AD, Assurance) to serve as a key leader within the US Patient Support Center of Excellence (COE) Program Quality team. Reporting to the Director of Program Quality, the AD provides operational leadership for the execution of the assurance program across Cystic Fibrosis, Kidney, and Hematology Patient Support Programs (PSPs) supporting both GxP and non-GxP functions. The Associate Director will provide oversight for the execution of quality assurance activities, including internal audits and continuous monitoring, corrective and preventive action (CAPA) management, and quality reporting.  In collaboration with the Director, the role will partner closely with Patient Support Teams (PST), Compliance, Legal, Privacy, Internal Audit, and other cross-functional stakeholders to ensure compliance with regulatory standards and other operating requirements. As a people leader, the Associate Director will develop and empower a high-performing team while driving proactive quality initiatives that strengthen the patient and provider experience, mitigate risk, and improve operational performance.

Key Duties and Responsibilities: Assurance Audit, Monitoring, and Compliance Oversight • Oversee the execution of all internal PSP audit and monitoring activities to evaluate regulatory compliance, customer experience, and adherence to program requirements and standard operating procedures. Scope includes but not limited to PSP communication monitoring, compliance events, deviations, and pharmacovigilance activities. • Analyze monitoring and audit results to identify emerging risks, systemic issues, and opportunities for process improvement as well as provide visibility into performance and risk areas across PSPs • Partner closely with the Director and PSP stakeholders to ensure appropriate steps are taken to address audit findings/observations of nonconformance •  Ensure effective management, tracking and timely closure of CAPAs • Support organizational readiness for internal, external, and regulatory inspections or assessments • Collaborate with the Director of Program Quality to maintain and advance the PSP Assurance Strategy, work instructions, quality standards, and monitoring methodologies. • Other responsibilities as assigned by the Director.

Cross-Functional Partnership • Facilitate governance discussions related to audit findings, compliance events, monitoring trends, and remediation strategies. • Identify opportunities for operational efficiencies and continuous improvement and partner with colleagues in other disease areas to share learnings / best practices • Manage current and future cross-functional assurance projects to improve processes that support the multilayered PST (e.g., guidance regarding community events, creating a template of shared resources between the PST and the field) • With guidance from the Director, partner closely with OBIE, Legal, Privacy, and Internal Audit teams to ensure effective management of quality and compliance risks.

People Leadership • Lead, coach, and develop a team of quality professionals responsible for executing assurance activities across multiple patient support programs. • Establish clear performance expectations and foster a collaborative, inclusive, and results-oriented team environment. • Promote innovation, critical thinking, and continuous improvement among team members.

Required Knowledge and Skills: • Demonstrated expertise in developing and executing risk-based assurance programs within highly regulated environments. • In-depth knowledge and demonstrated application of key quality management principles including: • Root cause analysis tools and methodologies • CAPA development and management • Audit and inspection readiness including development of auditing and monitoring tools and procedures

• Ability to independently drive results with urgency and operate effectively in a fast-paced, dynamic environment • Proven ability to evaluate quality matters and make complex decisions leveraging technical experience, advanced judgement, and the analysis/synthesis of a variety of information • Strong analytical, strategic thinking, and problem-solving skills, with the ability to assess risk, identify gaps, and implement practical, compliant solutions. • Excellent written, verbal, presentation, and facilitation skills, including the ability to tailor communications to different audiences • Advanced project management and execution skills, including the ability to lead complex, cross-functional initiatives; develop and manage project plans and ensure timely completion of key deliverables. • Understands how systems and databases are structured and can consolidate multiple data sources, and synthesize large datasets into key findings and recommendations • Intermediate proficiency in data analysis and visualization tools such as Microsoft Excel, Power BI, Tableau • Demonstrated ability to influence and build strong partnerships across matrixed organizations with diverse stakeholder groups. • Proven people leadership experience with a track record of coaching, developing, and retaining high-performing teams.

Education and Experience: • Minimum: A bachelor’s degree with 5+ years pharmaceutical/biotech/healthcare industry experience AND 5+ years hospital/biopharmaceutical patient support quality management experience with progressive responsibility in quality, compliance, audit, monitoring, or patient support program operations • Experience in pharmaceutical GxP auditing, monitoring, and quality management systems required • Minimum of 3 years of direct people leadership experience preferred. • Exposure to Salesforce platforms, including Service Cloud, Health Cloud, and/or Life Sciences Cloud. • Strong executive communication and presentation skills, including the ability to develop compelling presentations and quality r

Similar jobs

• Associate Director Quality Assurance — Catalent · Philadelphia, PA
• Associate Director, Quality Assurance Compliance — Gilead Sciences · Foster City, California, United States | United States – Remote
• Associate Director, Computer Systems Assurance (Quality) — Nurix · Brisbane, CA
• Senior Associate Quality Assurance — Amgen · Thousand Oaks, California, United States
• Program & Project Management Associate Director — University of Wisconsin-Madison · Remote
• Director, Quality Assurance — Insitro · South San Francisco, CA
• Director, Quality Assurance — Scopely · US - United States
• Assurance Compliance Director — Coastal · Remote