Datavant · 3 days ago
Director, Quality - Life Sciences
United States
Full-time
Remote
Director/Executive
$165K/yr - $230K/yr
8+ years expDatavant is a data platform company and the world’s leader in health data exchange. They are seeking a strategic and hands-on Director of Quality to lead product and supplier quality assurance efforts within their Life Sciences business unit, ensuring compliance and operationalizing their Quality Management System across stakeholders.
BiopharmaClinical TrialsData IntegrationHealth CareSoftware
No H1B
Hiring Manager
Brett Campbell
Responsibilities
Lead the development and continuous improvement of Datavant’s QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance
Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring
Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation
Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring
Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives
Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners)
Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP
Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation
Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3)
Represent Datavant’s quality program in external communications, including client onboarding, RFIs, and quality-related escalations
Qualification
Required
8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations
Strong working knowledge of relevant regulations and frameworks, including FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA, and GDPR
Proven leadership in scaling and operationalizing a QMS in a SaaS, RWD, or GxP context
Experience managing and mentoring cross-functional teams
Demonstrated success overseeing validation, supplier oversight, internal audits, and CAPA management
Deep understanding of data governance, privacy, and security best practices
Experience interacting with external auditors, customer compliance teams, or regulatory agencies
Strong communication skills—capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders
Preferred
Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions
Background working in or with tokenization, health data linkage, or privacy-enhancing technologies
Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams
Training or certification in Six Sigma, ISO Auditing, or software validation methodologies
Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl)
Experience contributing to industry working groups on quality, data integrity, or health data compliance
Company
Datavant
Datavant protects, connects, and delivers the world’s health data to power better decisions and advance human health.
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
$80.5MKey Investors
Transformation Capital
2020-10-08Series B· $40M
2018-04-30Series Unknown· $40.5M
Leadership Team
Carter Smith
Strategic Partnerships
Jasmin Phua
Head of Health Systems and Government Solutions
Recent News
2025-12-31
2025-12-19
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