Director, Quality - Life Sciences

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.

What You Will Do

• 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.

What You Need to Succeed

• 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.

What Helps You Stand Out

• 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.

#LI-BC1

To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.

This job is not eligible for employment sponsorship.

Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here. Know Your Rights, explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. 

At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren’t even able to see whether you’ve responded.) Responding is entirely optional and will not affect your application or hiring process in any way.

Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, by selecting the ‘Interview Accommodation Request’ category. You will need your requisition ID when submitting your request, you can find instructions for locating it here. Requests for reasonable accommodations will be reviewed on a case-by-case basis.