Director, Quality - Life Sciences

divh2Director Of Quality/h2pDatavant is a data platform company and the worlds 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 worlds leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, youre stepping onto a high-performing, values-driven team. Together, were rising to the challenge of tackling some of healthcares 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 Datavants Quality Management System (QMS) across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments./ppWhat You Will Do/pulliLead the development and continuous improvement of Datavants QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance./liliManage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring./liliServe 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./liliOversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring./liliEstablish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives./liliSupport readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners)./liliPartner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP./liliLead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation./liliEnsure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3)./liliRepresent Datavants quality program in external communications, including client onboarding, RFIs, and quality-related escalations./li/ulpWhat You Need To Succeed/pulli8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations./liliStrong working knowledge of relevant regulations and frameworks, including FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA, and GDPR./liliProven leadership in scaling and operationalizing a QMS in a SaaS, RWD, or GxP context./liliExperience managing and mentoring cross-functional teams./liliDemonstrated success overseeing validation, supplier oversight, internal audits, and CAPA management./liliDeep understanding of data governance, privacy, and security best practices./liliExperience interacting with external auditors, customer compliance teams, or regulatory agencies./liliStrong communication skillscapable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders./li/ulpWhat Helps You Stand Out/pulliPrior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions./liliBackground working in or with tokenization, health data linkage, or privacy-enhancing technologies./liliExperience interfacing directly with pharmaceutical, biotech, or CRO quality teams./liliTraining or certification in Six Sigma, ISO Auditing, or software validation methodologies./liliFamiliarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl)./liliExperience contributing to industry working groups on quality, data integrity, or health data compliance./li/ulpDatavant is committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. 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. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is: $165,000$230,000 USD 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./p/div