Care Access · 18 hours ago
Senior Director, Quality
United States
Full-time
Remote
Director/Executive
$175K/yr - $225K/yr
7+ years expCare Access is working to make the future of health better for all. The Senior Director, Quality will lead the development and execution of Care Access’s quality program across clinical, operational, and technology domains, ensuring a risk-based Quality Management System that supports the company's mission.
Clinical TrialsHealth Care
No H1B
U.S. Citizen Only
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
Qualification
Required
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
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
Demonstrated success building or scaling fit-for-purpose quality programs
Preferred
Prior experience in a start-up, hybrid, or tech-enabled clinical research environment strongly preferred
Benefits
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Company
Care Access
Care Access helps people learn more about their health and participate in clinical research to help find new medicines and cures.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Biomedical Advanced Research and Development Authority (BARDA)
2024-08-26Grant
Leadership Team
Ahmad Namvargolian
CEO, Co-Founder
Recent News
Company data provided by crunchbase