Remote Digital Quality & GxP Manager for SaaS/AI

OpenKrill; United States; Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

PTO & Holidays

100% Employer paid medical, dental, &

Job summary

Care Access seeks a Digital Quality & GxP Manager to support quality across software, AI, and health technologies. You will lead compliance programs, participate in audits, and guide lifecycle quality from development through deployment.

Join a remote, US-based role driving regulatory alignment, risk mitigation, and data integrity across SaaS products and clinical systems. Strong collaboration and regulatory expertise are essential.

Qualifications

• Certifications in GxP quality, computer systems validation processes or quality systems management preferred.
• 3+ years of experience implementing GxP standards and advising on quality compliance at a SaaS company, including GxP systems validation.

Responsibilities

• Review and approve validation of software and AI products to ensure full regulatory compliance.
• Prepare for and support external regulatory audits; lead internal or vendor audits related to GxP compliance.
• Develop and maintain digital/software components of quality management systems, including AI quality management systems.
• Proactively monitor systems and processes to ensure SOPs, audit compliance and industry best practices.
• Review key vendors for compliance with digital quality requirements.
• Train internal stakeholders on quality processes and best practices.
• Perform other tasks and special projects as directed by quality leadership.

Skills

Leadership

GxP Compliance

SaaS

Agile

Communication

Analytics

Detail‑oriented

Data Management

Time Management

Multitasking

Education

GxP Certifications

Job description

Care Access seeks a Digital Quality & GxP Manager to support quality across software, AI, and health technologies. You will lead compliance programs, participate in audits, and guide lifecycle quality from development through deployment.

Join a remote, US-based role driving regulatory alignment, risk mitigation, and data integrity across SaaS products and clinical systems. Strong collaboration and regulatory expertise are essential.