Source Job

$110,000–$140,000/yr
US

  • 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.

GxP SaaS Agile Quality Management Audit

20 jobs similar to Digital Quality & GxP Manager

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$85,000–$115,000/yr
US

  • Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
  • Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
  • Assist with tracking study payments and providing operational support across the full study lifecycle.

The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.

US

  • Conduct clinical audits and risk assessments to identify compliance gaps.
  • Manage multiple client engagements and deliver accurate project results.
  • Build strong client relationships and present findings to leadership.

Kodiak Solutions transforms healthcare through technology-driven solutions, specializing in finance, unclaimed property, and risk management. Their innovative platform streamlines operations, allowing providers to focus on patient care.

US

  • Support end-to-end eQMS implementations for life sciences organizations, coordinating timelines, deliverables, and risks.
  • Participate in system configuration, data migration, validation documentation, and UAT to ensure regulatory and data integrity compliance.
  • Collaborate with Quality, IT, Validation, vendors, and client teams across all implementation phases, including go-live and post-implementation support.

The hiring partner company supports end-to-end Quality Management System implementations for life sciences clients. They offer a remote contract-to-hire opportunity with potential for long-term growth.

US 5w PTO

  • Administer and support GxP and Quality systems (eQMS, CMMS, validation platforms) to ensure compliance and reliability.
  • Manage user access, SSO/SCIM, system configurations, and validation/change control activities.
  • Investigate incidents, support audits, and collaborate with IT, Quality, and vendors for inspection readiness.

This company provides technology-enabled services in regulated industries, supporting GxP and quality systems for clients. It offers a collaborative and inclusive environment that values diversity, integrity, and professional growth.

India

  • Lead the development and execution of Computer System Validation (CSV) and Computer Software Assurance (CSA) strategies, plans, and protocols.
  • Ensure GxP-regulated systems comply with FDA, ISO, and other global regulatory requirements through risk-based validation and documentation.
  • Collaborate with IT, Quality, Engineering, and Manufacturing teams to support compliant system implementations and lifecycle management.

The company is a technology-driven organization in the healthcare and life sciences sector, focused on ensuring the safety, quality, and reliability of computerized systems used in regulated environments. It fosters a collaborative culture that values continuous improvement, professional growth, and cross-functional teamwork.

US

  • Oversee delegated audits related to UM, Credentialing, Claims, Enrollment, and Appeals processes to ensure compliance with payer contracts.
  • Educate staff, update policies and workflows, and act as a liaison between payers and local market leadership during audits.
  • Operationalize regulatory communications from governing bodies and document process changes for upstream and downstream teams.

Dignity Health Management Services offers integrated management and business services to healthcare providers, focusing on managed care administrative and clinical services to contain costs and improve quality. It is part of CommonSpirit Health, a large health system with a mission-driven culture centered on community and patient care.

France

  • Oversee GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
  • Maintain inspection readiness and support CRO oversight per ICH E6(R3).
  • Collaborate with Data and Clinical teams to embed compliance into workflows and train teams.

Resilience Care is a French medtech founded in 2021, offering AI remote monitoring for oncology, gastroenterology, and psychiatry. It serves 35,000 patients across 200+ facilities with an agile, collaborative culture.

$100,000–$115,000/yr
US Unlimited PTO

  • Lead clinical quality and accreditation readiness for Pelago's care programs.
  • Run clinical audits and co-lead the Quality and Safety Committee.
  • Translate Joint Commission requirements into practical guidance and drive improvements.

Pelago is a specialty substance use and mental health care provider that combines technology with clinical expertise to deliver personalized treatment. They partner with employers and health plans and have supported over 750,000 members with substance use care.

US

  • Execute functional and regression tests on completed campaign builds to verify timing, routing, and message behavior end to end.
  • Own a queue of QC cases from intake to documented close, prioritizing by urgency and launch dates.
  • Partner with Build and Product Engineering to document and communicate defects clearly.

Drips engages people in two-way, compliance-governed SMS conversations through automated text and phone campaigns, helping organizations connect with customers at scale. Drips is a remote-first team that values accuracy, thoroughness, and clear documentation.

North Carolina

  • Conduct quality audits and validate provider data to ensure accuracy, integrity, and compliance with regulatory standards.
  • Analyze trends, investigate discrepancies, and recommend corrective actions to strengthen provider network operations.
  • Collaborate with cross-functional teams to document evidence, support accreditation reviews, and drive continuous improvement.

Alliance Health is a managed care organization that coordinates services for individuals with complex needs in North Carolina. They foster a collaborative, mission-driven culture focused on quality, compliance, and remote work flexibility.

$125,000–$150,000/yr
US

  • Lead operational execution of enterprise security, risk, compliance, and AI governance programs.
  • Manage external audits (SOC 2, ISO 27001, HITRUST, FISMA, HIPAA, PCI-DSS) and coordinate control owners.
  • Drive remediation, maintain risk registers, and establish year-round compliance operating model.

The company is hiring a Senior GRC and Compliance Manager to lead enterprise security compliance and governance programs through a partner platform. It provides a remote, team-oriented work environment with opportunities for professional growth and a comprehensive benefits package.

US Unlimited PTO

  • Perform risk-based exploratory, functional, regression, and integration testing across complex SaaS systems, APIs, databases, and document-processing pipelines.
  • Use AI as a testing co-pilot to analyze code changes, generate test scenarios, investigate issues, and improve coverage across user interfaces and backend services.
  • Collaborate with engineers and product managers to establish testable acceptance criteria, reproduce production issues, and maintain targeted automated checks with tools like Playwright.

They operate a technology platform that processes critical legal documents and workflows. The company is a fast-moving, AI-assisted engineering organization with a collaborative, quality-focused culture.

US

  • Own the full post-sale journey for Kivo's customers, driving outcomes, retention, and expansion.
  • Lead end-to-end implementations of the Kivo platform, from solution design and configuration to validation and go-live support.
  • Serve as strategic partner and primary account point of contact, managing account health and partnering with Sales on expansion opportunities.

Kivo is a life-sciences SaaS platform specializing in quality management for pharmaceutical, biotech, and medtech organizations. It is a hyper-growth, fast-paced company focused on delivering customer success in regulated environments.

US

  • Own the vision, strategy, and roadmap for the regulatory product portfolio, driving products from discovery to launch and optimization.
  • Translate complex healthcare and regulatory needs into scalable SaaS solutions while partnering with Engineering, Client Success, Sales, and Analytics.
  • Champion AI-enabled product development by leveraging tools like Claude, ChatGPT, and Gemini to accelerate research, prototyping, and workflows.

Quest Analytics helps health plans and regulators navigate healthcare’s most complex challenges, including network adequacy, provider access, and regulatory compliance. For over 20 years, 90% of America’s health plans have used their tools, and they maintain an entrepreneurial culture that values employee contributions.

$80,000–$90,000/yr
US

  • Support day-to-day execution of IT risk, compliance, privacy, and governance programs.
  • Review client agreements and security questionnaires, coordinating redlines with legal.
  • Manage control evidence, vendor risk, data retention, and compliance policies.

Our partner provides IT risk, compliance, privacy, and governance services for clients. They have a small, collaborative team and value diverse perspectives and authentic contributions.

$130,000–$150,000/yr
US 5w PTO

  • Administer the lifecycle of GxP and Quality governed systems including eQMS, CMMS, and Digital Validation applications.
  • Perform user account administration, role-based access control, and periodic access reviews.
  • Support Computer Software Assurance activities, change control, and CAPA investigations.

CAI is a professional services company established in 1996 that provides accelerated operational readiness and high-standard performance for mission-critical industries. The company has grown to nearly 800 employees worldwide and fosters a culture of integrity, service, and excellence.

$84,500–$162,000/yr
US

  • Execute the clinical audit program, including scheduling, planning, reporting, and resolution of audits.
  • Ensure compliance with worldwide regulations, ICH-GCP, AbbVie policies, and sponsor requirements.
  • Provide advice and support on GCP and quality topics to business partners and support inspections.

AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. It is a large biopharmaceutical company committed to integrity, innovation, and community service.

US

  • Conduct compliance reviews, monitoring, and testing across regulatory obligations.
  • Review and investigate potential compliance issues, document findings, and escalate as needed.
  • Support vendor compliance, customer due diligence, and AI governance programs.

April is an embedded, year-round tax platform that brings real-time tax intelligence into the platforms people already use. The company's AI-powered engine and API-first infrastructure serve complex tax situations, with a culture emphasizing ownership, judgment, and professionalism.

US Brazil

  • Lead Risk-Based Quality Management (RBQM) activities to ensure clinical trial quality and alignment with study objectives.
  • Oversee centralized monitoring, including developing Central Monitoring Plans, reviewing KRIs/QTLs, and maintaining dashboards.
  • Collaborate with global teams and sponsors to identify risks, recommend mitigations, and support inspection readiness.

A global clinical research organization focused on advancing medical innovation and improving patient outcomes through high-quality clinical trials. The company fosters a collaborative, multidisciplinary remote environment with international teams and a strong emphasis on regulatory compliance and data-driven decision-making.

$120,000–$140,000/yr
US Unlimited PTO

  • Develop and maintain test strategies, automated suites, and validation documentation for software releases.
  • Integrate automated testing into CI/CD pipelines and perform risk-based testing across critical functionality.
  • Collaborate with engineering, product, and quality teams to ensure traceability and regulatory compliance.

VivoSense is a science and technology company specializing in digital health technologies, including wearable sensors and connected monitoring tools. They partner with pharmaceutical sponsors, healthcare providers, and academic groups, operating as a small, collaborative organization where employees take significant ownership.