Digital Quality & GxP Manager

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

Benefits offered by this job

PTO and Holidays

100% Employer paid medical, dental, &

Health Savings Account and Flexible Sp

HSA employer contribution

Short-Term and Long-Term Disability

401(k) Retirement Plan with company-m"

Job summary

Care Access seeks a Digital Quality & GxP Manager to join our Quality team and guide GxP quality across the software product lifecycle, including AI systems, at a fast-paced technology company.

You will build strong relationships with internal and external stakeholders to achieve regulatory readiness, audits, and ongoing compliance while working in a remote US environment.

Qualifications

• 3+ years implementing GxP standards at a SaaS company
• Experience with Good Clinical Practice is required
• Experience with SaaS applications and agile product development methodology
• Excellent communication and interpersonal skills
• Strong analytical and time-management skills
• Highly detail-oriented with the ability to manage multiple deadlines

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 quality components of quality management systems, including AI quality systems
• Proactively monitor systems to ensure SOPs, audits, and best practices are followed
• Review vendors for compliance with digital quality requirements
• Train internal stakeholders on quality processes and best practices
• Perform other tasks and special projects assigned by quality leadership

Skills

Leadership experience

Excellent communication

Analytical skills

Time management

Attention to detail

Stakeholder management

Education

GxP quality certifications

Tools

Agile methodologies

Job description

About Care Access

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 like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference 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.

To learn more about Care Access, visit www.CareAccess.com .

How This Role Makes a Difference

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

Minimum Education:

• Certifications in GxP quality, computer systems validation processes or quality systems management preferred.

Minimum Experience:

• 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 (US Full Time Employees)

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match

Mandatory Employer Disclosures

Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.

Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.

Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with appli