Director, Quality – Life Sciences

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Datavant

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Healthcare Insurance • SaaS • Enterprise

Datavant is a company that provides a platform and network focused on making health data secure, accessible, and usable across the healthcare ecosystem. With a focus on data connectivity and interoperability, Datavant facilitates the movement of healthcare records across a vast network of organizations, including hospitals, clinics, health systems, and data partners. Their suite of products and solutions covers areas such as health data exchange, data transformation, and privacy compliance, serving various clients including health plans, healthcare providers, life sciences, and government organizations. Datavant's mission is to advance human health through improved data exchange and analytics.

201 - 500 employees

Founded 2017

⚕️ Healthcare Insurance

☁️ SaaS

🏢 Enterprise

💰 $40M Series B on 2020-10

📋 Description

• 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.

🎯 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.

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Flexible work hours • Professional development opportunities