Director, Compliance & Quality Systems

Job not on LinkedIn

🔥 10 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

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Emerald Cloud Lab

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Emerald Cloud Lab is a biotechnology research company that provides researchers access to state-of-the-art scientific labs from anywhere in the world, available 24/7. By utilizing a single software interface, researchers can design, run, and analyze experiments more efficiently, allowing them to focus on protocol design and data analysis instead of time-consuming lab activities. This platform enhances productivity while reducing operational costs and environmental impact.

📋 Description

• Own ECL's Quality Management System (QMS) and finalize its design, build, and implementation toward GMP compliance • Lead ECL through its first client audits and regulatory inspections • Oversee everyday QMS operations and continuous compliance after establishment • Design the QMS to scale across current and future sites with consistent quality standards • Build and lead a focused team to drive GMP compliance • Own QMS processes including document control, deviations, OOS, CAPA, change control, risk management, equipment qualification, supplier quality, and GMP training • Monitor QMS execution through quality metrics, periodic reviews, and internal audits • Ensure the QMS meets client quality requirements and Quality Agreement terms, with accurate and timely client notifications • Embed quality and compliance requirements in ECL's software platform • Run Quality Management Reviews and report quality performance, risks, and resource needs to the executive team • Track regulatory, guidance, and standards changes and assess operational and client-work impact • 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 expand the internal audit program to new sites • Coordinate responses to audit observations and findings and track on-time closure • Maintain continuous inspection readiness • Manage client quality agreements and support qualification questionnaires and due diligence • Own supplier quality, including risk-based supplier selection, qualification, approved supplier list, and performance monitoring • Plan and conduct supplier audits and manage supplier corrective actions and change notifications • Establish and maintain quality agreements with critical suppliers • Own GMP training and deliver quality, data integrity, and inspection-readiness training • Build and lead the QMS team and partner with Quality leadership on strategy, priorities, and escalations

🎯 Requirements

• 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 • Preferred: Experience with ISO 9001 and/or ISO/IEC 17025 • Preferred: Experience with computerized system validation (GAMP 5) and highly automated or software-driven lab operations • Preferred: Working knowledge of software development, such as coding, the software development lifecycle (SDLC) and version control • Preferred: Quality certification such as ASQ CQA, CQE or CMQ/OE • Preferred: Experience in a contract service organization supporting clients with differing quality requirements

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