Digital Quality & GxP Manager (Fully Remote)

Care Access; United States; Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

100% employer paid medical, dental, &视

401(k) with company match and PTO

Job summary

Care Access is seeking a remote Quality Assurance role focused on GxP compliance for software and AI products. You will review validations, support regulatory audits, and maintain digital quality systems across the product lifecycle.

The role requires 3+ years in GxP at a SaaS company and experience with Good Clinical Practice, with strong analytical and communication skills. Fully remote within the United States.

Qualifications

• 3+ years implementing GxP standards at a SaaS company.
• Experience with Good Clinical Practice is required.
• Strong analytical, communication, and organizational skills.

Responsibilities

• Review and approve validation of software and AI products.
• Prepare for and support external regulatory audits; lead internal or vendor audits.
• Develop and maintain digital/software components of quality management systems.

Skills

GxP compliance

Good Clinical Practice

Analytical skills

Communication skills

Organizational skills

Job description

• Support Quality at Care Access and parent company Reify Health.
• Manage compliance risk and provide practical GxP guidance across the software product lifecycle.

Key Responsibilities:

• Review and approve validation of software and AI products.
• Prepare for and support external regulatory audits; lead internal or vendor audits.
• Develop and maintain digital/software components of quality management systems.

Requirements:

• 3+ years implementing GxP standards at a SaaS company.
• Experience with Good Clinical Practice is required.
• Strong analytical, communication, and organizational skills.
• 100% employer paid medical, dental, and vision insurance.
• 401(k) with company match and PTO.
• Fully remote role within the US.

Care Access

Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.