Senior Director, Quality

Care Access

9h•Remote

About The Position

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit www.CareAccess.com. The Senior Director, Quality will lead the development and execution of Care Access’s quality program across clinical, operational, and technology domains. This role is responsible for building and maintaining a risk-based, fit-for-purpose Quality Management System (QMS) that supports Care Access’s mission to accelerate clinical research and health services with innovation, integrity, and operational excellence. Operating at the intersection of Good Clinical Practice (GCP), technology, and health-related services, this leader will shape the vision for quality across the organization, balancing compliance requirements with practical, scalable solutions. The Senior Director will collaborate closely with Operational Compliance, Product, Privacy, IT, and other functional partners to embed quality by design across systems and workflows. This is a hands-on leadership role that requires both strategic foresight and tactical execution.

Requirements

Deep knowledge of Good Clinical Practice (GCP) and quality management principles.
Demonstrated expertise in Computer Systems Validation (CSV) and its application within GCP-regulated environments.
Strong understanding of how technology, data, and clinical operations intersect within a research or health services context.
Proven ability to develop and lead risk-based quality programs that support innovation and compliance simultaneously.
High level of accountability for personal and team performance, including the business consequences of quality decisions.
Timely responsiveness and communication with internal stakeholders; customer service mindset and collaborative approach.
Highly accessible and adaptable, with the ability to manage multiple competing priorities and provide quick, practical solutions.
Growth mindset and willingness to learn new skills and quality frameworks to meet evolving business needs.
Team player capable of leading and participating within cross-functional project teams to meet key milestones under tight timelines.
Professionalism and judgment in all interactions, with the ability to work effectively with individuals at all levels of the organization.
Ability to evaluate and escalate risk appropriately to ensure sound decision-making and business-oriented solutions.
Strong interpersonal and communication skills with a practical, problem-solving mindset.
Business-minded, collaborative, and decisive, able to navigate complex issues with professionalism and good judgment.
Critical thinker and problem solver with strong attention to detail.
Ability to work effectively in a fast-paced, dynamic, and remote environment.
Proper home office setup with private workspace and reliable high-speed internet (minimum: 100MB up / 15MB down, 5GHz router).
Must be currently authorized to work in the United States without the need for visa sponsorship. For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa.
Quality certifications in one or more relevant areas.
Bachelor’s degree in life sciences, health sciences, or a related field required; advanced degree preferred.
7-10+ years of progressive experience in quality roles within clinical research, health services, or related regulated industries.

Nice To Haves

Prior experience in a start-up, hybrid, or tech-enabled clinical research environment strongly preferred.
Demonstrated success building or scaling fit-for-purpose quality programs.

Responsibilities

Work cross-functionally to drive the continued implementation and evolution of Care Access’s enterprise Quality Management System (QMS).
Communicate a cohesive quality strategy aligned with business, legal and compliance, clinical, operational, and technology goals.
Collaborate with senior leadership to ensure quality informs decision-making, risk management, and operational planning.
Partner with Operational Compliance, Product, Privacy, IT, and other functions to ensure seamless integration of quality practices across domains.
Act as a key advisor on quality implications for new technologies, systems, and service models.
Manage, mentor, and develop Quality team members to support professional growth and organizational capability.
Promote a culture of quality by design, accountability, and operational excellence.
Lead through influence to embed quality principles across all Care Access functions.
Work cross-functionally with Operational Compliance, Product, Privacy, and IT teams to align on the application of relevant quality frameworks and sponsor/customer expectations.
Provide subject matter expertise and partnership to ensure quality principles are integrated throughout system design, development, and operational processes.
Support the maintenance and continuous improvement of quality documentation to enable scalability and compliance.
Develop and lead a risk-based quality oversight program that enables proactive issue identification and continuous improvement.
Establish and monitor quality metrics and KPIs to identify emerging risks and areas for improvement.
Drive consistent root cause analysis and CAPA management processes across teams.
Engage with sponsor and client quality teams using a customer service mindset, providing excellent responsiveness, exercising sound judgment, and ensuring timely and effective issue resolution.
Lead organizational audit readiness activities to ensure consistent preparedness for internal, sponsor, and regulatory inspections.
Oversee coordination and logistics for external audits and inspections across functional areas, ensuring timely and accurate responses.
Provide guidance and leadership in audit conduct, follow-up, and remediation planning.
Partner with Operational Compliance and other stakeholders to ensure lessons learned are integrated into continuous improvement efforts.
Manage, mentor, and develop Quality team members to support professional growth and organizational capability.
Promote a culture of quality by design, accountability, and operational excellence.
Lead through influence to embed quality principles across all Care Access functions.
Perform other quality tasks and special projects as assigned.