Director, Compliance & Quality Systems

Emerald Cloud Lab

About The Position

The Director, Compliance & Quality Systems owns ECL's Quality Management System (QMS), including finalizing its design, build, and implementation as a critical step toward GMP compliance. The director will lead ECL through its first client audits and regulatory inspections, then oversee everyday QMS operations and continuous compliance. ECL currently operates from one site and plans to expand to additional sites. The director will ensure the QMS is scalable so each site launches with the same quality standard, and will build and lead a focused team to drive GMP compliance. This hands-on leadership role shapes the QMS by embedding quality processes into ECL's software-driven laboratory platform, applying deep compliance expertise while adapting requirements to a connected environment.

Requirements

Bachelor's degree in life sciences, chemistry, engineering, or a 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 with regulatory inspections and client audits, including writing responses that closed findings.
Experience with an internal audit program, supplier quality program, and/or GMP training program.

Nice To Haves

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.

Responsibilities

Own ECL's QMS processes end to end, including document control, deviations, OOS, CAPA, change control, risk management, equipment qualification, supplier quality, and GMP training.
Monitor QMS execution at current and future sites using quality metrics, periodic reviews, and internal audits.
Ensure the QMS meets client quality requirements and Quality Agreement terms, and communicate required client notifications accurately and on time.
Embed quality and compliance requirements in ECL's single software platform.
Run Quality Management Reviews and report quality performance, risks, and resource needs to the executive team.
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, and translate them into readiness actions.
Represent ECL's quality and compliance position with external stakeholders.
Own and extend the internal audit program 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.
Own the supplier quality program, including risk-based supplier selection, qualification, the 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.
Own the GMP training program at current and future sites.
Deliver quality, data integrity, and inspection-readiness training, updating content as regulations and procedures change.
Build and lead a focused team supporting QMS and related activities.
Partner closely with Quality leadership on strategy, priorities, and escalations.