Senior Director, Quality

📋 Description

• • The Senior Director, Quality will lead the development and execution of Care Access’s quality program across clinical, operational, and technology domains, building and maintaining a risk-based, fit-for-purpose Quality Management System (QMS) that supports the mission to accelerate clinical research and health services with innovation, integrity, and operational excellence.
• • Day to day, the role involves working cross-functionally to implement and evolve the enterprise QMS, communicating a cohesive quality strategy aligned with business, legal, compliance, clinical, operational, and technology goals, collaborating with senior leadership to ensure quality informs decision-making and risk management, partnering with Operational Compliance, Product, Privacy, IT, and other functions to embed quality by design, acting as a key advisor on quality implications for new technologies and service models, managing and mentoring the Quality team, promoting a culture of quality by design and accountability, leading audit readiness activities, overseeing external audits and inspections, establishing and monitoring quality metrics and KPIs, driving root cause analysis and CAPA management, and engaging with sponsor and client quality teams using a customer service mindset.
• • Care Access is a global organization dedicated to making the future of health better for all, operating hundreds of research locations, mobile clinics, and clinician networks worldwide to bring world-class research and health services directly to underserved communities. Through initiatives like Future of Medicine and Difference Makers, the company puts people at the heart of medical progress by combining partnerships, technology, and perseverance to reimagine how clinical research and health services reach the world.
• • In this role, the individual will develop strategic foresight and tactical execution skills in quality leadership, gain deep expertise in GCP and CSV within tech-enabled health environments, lead the scaling of fit-for-purpose quality programs, influence organizational culture toward quality by design, and build executive-level collaboration skills while advancing Care Access’s mission to accelerate medical breakthroughs through compliant, innovative, and accessible health services.