Director, Compliance & Quality Systems

About the Role

Director, Compliance & Quality Systems Role Summary The Director, Compliance & Quality Systems owns ECL's Quality Management System (QMS). You will play an key role in finalizing the design, build, and implementation of the ECL QMS—a critical step toward GMP compliance—and you'll lead ECL through its first client audits and regulatory inspections. Once the QMS is established, you will oversee everyday operations and continuous compliance. ECL operates from a single site today and will expand to additional sites in the near future. You'll ensure the QMS is designed to scale, so all sites launch with the same quality standard. You'll build and lead a focused team to drive GMP compliance. This hands-on leadership role offers the opportunity to shape ECL's QMS, embedding quality processes directly into ECL's novel software-driven laboratory platform. We're looking for a leader with deep compliance expertise, as well as the curiosity and agility to reimagine how those requirements are met in a software-driven, connected environment. Key Responsibilities QMS Ownership: Own ECL's QMS processes end to end: document control, deviations, OOS, CAPA, change control, risk management, equipment qualification, supplier quality and GMP training Monitor QMS execution at current and future sites through quality metrics, periodic reviews, and internal audits Ensure the ECL QMS meets client quality requirements and the terms of each Quality Agreement, and that required client notifications are communicated accurately and on time Ensure quality and compliance requirements are embedded in ECL's single software platform Run Quality Management Reviews and report quality performance, risks, and resource needs to the executive team Regulatory Intelligence and Readiness: Track changes in applicable regulations, guidance and standards and assess their impact on ECL operations and client work Monitor inspection trends, warning letters and enforcement themes, & translate th

Requirements & Qualifications

• Strong problem solving foundations, knowledge of modern engineering practices, and interest in technology systems.

Perks & Benefits

• Official mentor support
• verified hiring timeline
• and career progression.