Digital Quality & GxP Manager

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 working to make the future of health better for all.With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care.We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need,and contribute to the medical breakthroughs of tomorrow.

With programs likeFuture of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, andDifference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

We are seeking a Digital Quality & GxP Manager to join our Quality team and help to support Quality at Care Access and our parent company Reify Health. This role will help to manage compliance risk and provide practical guidance on GxP quality at all stages of the software product lifecycle. The successful candidate will have hands‑on experience implementing GxP compliance at a fast‑paced technology company and will support quality for both internal and external software products, systems and AI products. Digital Quality & GxP Manager must build and maintain collaborative relationships with internal and external stakeholders to accomplish key business objectives across departments.

How You'll Make An Impact

• Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies
• Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance
• Development and maintenance of digital/software components of quality management systems, including AI quality management systems
• Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
• Review key vendors for compliance with digital quality requirements
• Train and educate internal stakeholders on quality processes and best practices
• Perform other tasks and special projects assigned by quality leadership

The Expertise Required

• Demonstrated leadership experience in implementing compliance programs within the software industry. Project management experience preferred.
• Experience with Good Clinical Practice is required
• Demonstrated experience with SaaS application and agile product development methodology.
• Excellent communication and interpersonal skills
• Strong analytical skills with the ability to effectively define business issues and recommendations
• High attention to detail and organizational skills
• Technical proficiency and understanding of data management in healthcare or clinical trial spaces
• Highly detail‑oriented with strong time management skills to manage multiple deadlines
• Ability to work with minimal supervision and manage multiple priorities in a fast-paced environment

Certifications/Licenses, Education, and Experience

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

How We Work Together

• Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
• Travel: This is a remote position with travel requirements up to 40%. Occasional planned travel may be required as part of the role.
• Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

The expected pay range for this role is $110,000 - $140,000 USD per year for full time team members.

Benefits & Perks (