Director, Quality - Life Sciences

Datavant•New York City, NY

12d

About The Position

Datavant is a data platform company and the world’s leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world’s leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you’re stepping onto a high-performing, values-driven team. Together, we’re rising to the challenge of tackling some of healthcare’s most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on Director of Quality to lead product and supplier quality assurance efforts within our Life Sciences business unit , which includes the Datavant Connect and Aetion Evidence Platform . These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant’s Quality Management System (QMS) across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments.

Requirements

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.

Nice To Haves

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.

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.