Digital Quality & GxP Manager

The posting, as Care Access wrote it

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 e

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ection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
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Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
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Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com