Sr. Director, Data Quality, Compliance and Documentation

The Senior Director, Quality & Compliance will be responsible for leading the quality and compliance functions for Zelta.

Reporting directly to the GM and leading a team of seven, the Senior Director will shape and execute Zelta’s quality and compliance strategy, ensuring that best practices, product quality, and regulatory adherence scale with the company’s rapid growth. This leader will oversee the development, governance, and continuous improvement of Zelta’s SaaS and services business; ensure compliance with global regulatory frameworks; and partner cross-functionally to embed quality and operational excellence across the business. 

This is a unique opportunity to guide a mission-critical function within a high-growth clinical technology platform backed by cutting-edge technology, a robust customer footprint, and a large addressable market. The Senior Director will ensure that Zelta’s products, processes, and delivery meet the highest standards of accuracy, consistency, audit readiness, and regulatory compliance. 

The role requires an enterprise-minded leader capable of balancing risk management with business enablement, driving operational rigor while supporting innovation and speed. The Senior Director will collaborate closely with the GM, Product, Engineering, Delivery, and other senior leaders to ensure Zelta’s products and processes meet evolving market, customer, and regulatory demands.

Primary 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. 

Key Outcomes 

• Develop and implement a unified framework that scales with business growth. 

• Build a best-in-class quality and compliance infrastructure that enhances product usability, auditability, and regulatory alignment. 

• Establish measurable quality and compliance processes across audits, SOPs, CAPA, and release readiness. 

• Ensure Zelta meets or exceeds regulatory expectations for cloud-based clinical research platforms. 

• Drive a culture of integrity, operational rigor, and continuous improvement across the organization. 

• Enhance transparency, accountability, and cross-functional collaboration in all quality and compliance initiatives. 

• Effectively represent Zelta in the industry, and with clients and regulators. 

Professional Experience & Qualifications 

The ideal Senior Director will be a proven leader in quality assurance and compliance within cloud-based life sciences, clinical research, or healthcare technology environments. Experience supporting regulated, enterprise-scale SaaS platforms is strongly preferred.

Qualifications include: 

• 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. 

Education 

A bachelor’s degree from an accredited institution is required. A graduate degree (MBA or similar) is preferred.