Director, Compliance & Quality Systems

Emerald Cloud Lab

. Own ECL's Quality Management System (QMS) and finalize its design, build, and implementation toward GMP compliance .

Posted 11/10/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) design and implementation for GMP compliance, with a strong focus on regulatory inspections, internal audits, and supplier quality management. Proven ability to lead teams and embed quality standards across operations while ensuring continuous compliance and inspection readiness.

Highest-signal resume keywords

GMP ComplianceQuality Management System (QMS)Regulatory InspectionsInternal Audit ProgramSupplier Quality Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceQuality ControlDocument ControlCAPARisk ManagementGMP TrainingData IntegrityRegulatory ComplianceComputerized System ValidationQuality Metrics

Soft Skills

LeadershipTeam BuildingCommunicationProblem SolvingCollaboration

Tools & Technologies

Quality Management SoftwareGMP Training PlatformsAudit Management ToolsDocument Management SystemsData Integrity Tools

Certifications & Qualifications

ASQ CQACQECMQ/OE

Industry Keywords

BiopharmaCDMOISO 9001ISO/IEC 1702521 CFR Parts 210/21121 CFR Part 11EU Annex 11ALCOA+Contract Service OrganizationQuality Agreement

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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

What you’ll need

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