Digital Quality Manager – GxP

CARE

. Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies .

Posted 10/14/2026full-timeRemote • United StatesMid-LevelSenior💰 $110,000 - $140,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in implementing compliance programs within the software industry, with a strong focus on GxP standards and quality management systems. Proficient in SaaS application development and regulatory compliance, with excellent communication and analytical skills to support internal and external audits.

Highest-signal resume keywords

GxP Standards ImplementationSaaS Application DevelopmentGood Clinical PracticeQuality Management SystemsRegulatory Compliance Audits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GxP Systems ValidationData ManagementAgile Product DevelopmentQuality ComplianceAudit Compliance

Soft Skills

Excellent CommunicationInterpersonal SkillsAnalytical SkillsAttention to DetailOrganizational Skills

Certifications & Qualifications

GxP Quality CertificationComputer Systems Validation CertificationQuality Systems Management Certification

Industry Keywords

Regulatory RequirementsDigital Quality RequirementsHealthcare ComplianceClinical Trial StandardsQuality Processes

About the role

Key responsibilities & 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
Develop and maintain digital/software components of quality management systems, including AI quality management systems
Proactively monitor systems and processes for 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
Build and maintain collaborative relationships with internal and external stakeholders across departments
Travel up to 40% as required

Requirements

What you’ll need

Demonstrated leadership experience in implementing compliance programs within the software industry
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
3+ years of experience implementing GxP standards and advising on matters of quality compliance at a SaaS company, including GxP systems validation
Certifications in GxP quality, computer systems validation processes or quality systems management preferred
Must be able to work remotely within the United States
Care Access is unable to sponsor work visas at this time

Benefits

Comp & perks

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