Senior Manager, GxP & Digital Quality

📋 Description

• • The Senior Manager, GxP & Digital Quality will play a critical role in ensuring regulatory compliance and quality standards across Care Access’s software, AI, and digital health products, directly supporting the company’s mission to expand equitable access to clinical research and healthcare services.
• • Day-to-day responsibilities include reviewing and approving software and AI product validations, preparing for and leading internal and external audits, maintaining digital quality management systems, monitoring compliance with SOPs and industry best practices, evaluating vendor compliance, and training internal teams on quality processes.
• • Care Access is a mission-driven organization with hundreds of research locations, mobile clinics, and global clinicians dedicated to breaking down barriers to care through initiatives like Future of Medicine and Difference Makers, partnering with communities and technology to advance health equity.
• • In this role, the individual will deepen expertise in GxP compliance within SaaS and AI environments, lead cross-functional quality initiatives, influence product lifecycle decisions, and develop leadership skills in managing complex compliance programs in a fast-paced, innovative healthcare technology setting.