Remote GxP Quality Lead for SaaS & AI

Care Access; Boston (MA); Remote; USD 110,000 - 140,000; Full time

Job summary

Care Access is seeking a Digital Quality & GxP Manager to join the Quality team. You will manage compliance risk and provide practical guidance on GxP quality across software product lifecycles, supporting internal, external products and AI systems.

The role emphasizes hands-on GxP implementation in a fast-paced tech environment with collaboration across departments. You will build relationships with stakeholders, prepare for audits, and lead digital quality initiatives that align with

Qualifications

• Experience implementing compliance programs in software; project management preferred.
• Good Clinical Practice experience required.
• Familiar with SaaS and agile product development methodologies.
• Strong communication and analytical skills.
• Detail-oriented with the ability to manage multiple deadlines and priorities.

Responsibilities

• Review and approve validation of software and AI products for compliance.
• Prepare for and support regulatory audits; lead internal or vendor audits related to GxP compliance.
• Develop and maintain digital quality management systems, including AI quality systems.
• Proactively monitor systems to ensure SOPs and audit readiness.
• Train internal stakeholders on quality processes and best practices
• Perform other tasks and special projects assigned by quality leadership

Skills

Leadership

GxP knowledge

SaaS experience

Agile development

Communication

Analytical thinking

Time management

Self-management

Education

GxP certifications (preferred)

Job description

Care Access is seeking a Digital Quality & GxP Manager to join the Quality team. You will manage compliance risk and provide practical guidance on GxP quality across software product lifecycles, supporting internal, external products and AI systems.

The role emphasizes hands-on GxP implementation in a fast-paced tech environment with collaboration across departments. You will build relationships with stakeholders, prepare for audits, and lead digital quality initiatives that align with