Merative · 5 days ago
Sr. Director, Data Quality, Compliance and Documentation
United States
Full-time
Remote
Director/Executive
$172K/yr - $258K/yr
10+ years expMerative is dedicated to improving health outcomes through data, analytics, and software for the health industry. The Senior Director, Quality & Compliance will lead the quality and compliance functions for Zelta, ensuring best practices, product quality, and regulatory adherence while collaborating across teams to drive operational excellence and support innovation.
AnalyticsHealth CareInformation TechnologyIT Infrastructure
Responsibilities
Oversee the creation, governance, and maintenance of all product, operational, and compliance related materials
Implement a scalable strategy ensuring accuracy, consistency, version control, and accessibility across teams
Standardize templates, processes, and tools to support internal operations and customer-facing content
Ensure product, processes, and delivery align with regulatory requirements and support product adoption, regulatory & client audits, and client quality & compliance needs
Lead the development and execution of Zelta’s quality management strategy, aligning it to organizational goals and regulatory expectations
Establish and evolve quality processes, including audits, CAPA, SOPs, and quality metrics
Create and maintain compliance frameworks in alignment with GxP, FDA/EMA regulations, ISO standards, and other relevant guidelines
Conduct ongoing analysis of regulatory changes and market dynamics to ensure Zelta remains audit-ready and future-proof
Implement clear goals, KPIs, and accountability structures to drive operational excellence
Partner with cross-functional leaders to embed quality, compliance, and best practices throughout the organization
Work closely with Product and Engineering to ensure new product releases meet quality and compliance standards, supported by robust documentation
Partner with Operations and Customer Success to ensure quality and compliance programs support client satisfaction and readiness for audits or regulatory submissions
Collaborate with Finance and the GM to ensure the quality and compliance roadmap aligns with business priorities and resource planning
Establish scalable systems for product lifecycle management, compliance tracking, and quality reporting
Implement continuous improvement programs to enhance process efficiency, reduce risk, and improve product and operational quality
Serve as a subject-matter expert and spokesperson for quality and compliance matters internally and externally
Qualification
Required
Minimum of 10 years of progressive experience in quality, compliance, or regulatory operations within life sciences or healthcare technology
Deep understanding of clinical development, GxP, and regulatory frameworks relevant to digital clinical platforms
Proven experience building and scaling quality and compliance programs in complex, high-growth environments
Demonstrated ability to lead teams, establish processes, and implement metrics-driven quality and compliance systems
Strong orientation toward operational excellence, risk management, and continuous improvement
Executive presence and strong communication skills, with the ability to influence cross-functional leaders and external stakeholders
Experience working in matrixed organizations, ideally with private equity ownership or accelerated growth expectations
Track record of building high-performance teams and fostering a culture of accountability, engagement, and transparency
Ability to balance regulatory rigor with business goals, supporting product innovation while ensuring compliance
A bachelor's degree from an accredited institution is required
Preferred
Experience supporting regulated, enterprise-scale SaaS platforms is strongly preferred
A graduate degree (MBA or similar) is preferred
Benefits
Remote first / work from home culture
Flexible vacation to help you rest, recharge, and connect with loved ones
Paid leave benefits
Health, dental, and vision insurance
401k retirement savings plan
Infertility benefits
Tuition reimbursement, life insurance, EAP – and more!
Company
Merative
Merative is an IT services company that offers products to improve decision-making and performance. It is a sub-organization of IBM.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2022-01-25Acquired
2018-03-29Series A
Leadership Team
Gerry McCarthy
Chief Executive Officer and Board Director
Troy Bailey
Chief Technology Officer
Recent News
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