Director, Compliance & Quality Systems

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 complia nce 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 them into concrete readiness actions

Represent ECL's quality and compliance position with external stakeholders

Audits and Inspections

Own the internal audit program, extending it to each new site as it opens

Coordinate responses to observations and findings and track them to on-time closure

Maintain continuous inspection readiness

Manage client quality agreements and support client qualification questionnaires and due diligence

Supplier Quality

Own supplier quality program: risk-based supplier selection, qualification, approved supplier list and ongoing performance monitoring

Plan and conduct supplier audits; manage supplier corrective actions and change notifications

Establish and maintain quality agreements with critical suppliers of instruments, reagents, consumables and services

Training

Own the GMP training program at current and future sites

Deliver quality, data integrity, and inspection-readiness training, u pdating content as regulations and procedures change

Leadership

Build and lead a focused team supporting QMS and related activities

Partner closely with the Quality leadership on strategy, priorities, and escalations

Qualifications

Required:

Bachelor's degree in life sciences, chemistry, engineering, or related field

10+ years in quality assurance or compliance in a regulated laboratory, CDMO or biopharma environment

3+ years leading QA or QC teams

Deep working knowledge of GMP requirements, including 21 CFR Parts 210/211 and data integrity expectations (21 CFR Part 11, EU Annex 11, ALCOA+)

Direct experience in regulatory inspections and client audits, and writing responses that closed findings

Experience with an internal audit program, supplier quality program and/or a GMP training program

Preferred

Advanced degree (MS or PhD) in a scientific discipline

Experience with ISO 9001 and/or ISO/IEC 17025

Experience with computerized system validation (GAMP 5) and highly automated or software-driven lab operations

Working knowledge of software development, such as coding, the software development lifecycle (SDLC) and version control

Quality certification such as ASQ CQA, CQE or CMQ/OE

Experience in a contract service organization supporting clients with differing quality requirements