Director, Compliance & Quality Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of ECL's Quality Management System (QMS) and complete its design, construction, and implementation to achieve GMP compliance.

• Guide ECL through its initial client audits and regulatory inspections.

• Supervise daily QMS operations and ensure ongoing compliance post-establishment.

• Develop the QMS to be scalable across existing and future sites while maintaining uniform quality standards.

• Assemble and lead a dedicated team to promote GMP compliance.

• Manage QMS processes, which include document control, deviations, out-of-specification (OOS) results, corrective and preventive actions (CAPA), change control, risk management, equipment qualification, supplier quality, and GMP training.

• Assess QMS performance through quality metrics, routine reviews, and internal audits.

• Ensure the QMS aligns with client quality expectations and adheres to Quality Agreement stipulations, providing accurate and timely notifications to clients.

• Integrate quality and compliance requirements into ECL's software platform.

• Conduct Quality Management Reviews and communicate quality performance, risks, and resource needs to the executive team.

• Track changes in regulations, guidance, and standards while evaluating their impact on operations and client-related work.

• Observe trends in inspections, warning letters, and enforcement actions, translating them into readiness initiatives.

• Represent ECL's quality and compliance stance to external stakeholders.

• Manage and expand the internal audit program to cover new sites.

• Coordinate the responses to audit observations and findings, ensuring timely closure.

• Maintain a state of continuous inspection readiness.

• Oversee client quality agreements and assist with qualification questionnaires and due diligence processes.

• Manage supplier quality functions, including risk-based supplier selection, qualification, maintaining an approved supplier list, and performance monitoring.

• Plan and execute supplier audits, managing corrective actions and change notifications.

• Establish and uphold quality agreements with critical suppliers.

• Lead GMP training efforts and provide training on quality, data integrity, and inspection readiness.

• Build and lead the QMS team while collaborating with Quality leadership on strategy, priorities, and escalations.

⛳️ Requirements

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

• 10+ years of experience in quality assurance or compliance within a regulated laboratory, CDMO, or biopharma setting.

• 3+ years of experience leading QA or QC teams.

• In-depth knowledge of GMP requirements, including 21 CFR Parts 210/211 and data integrity standards (21 CFR Part 11, EU Annex 11, ALCOA+).

• Direct experience with regulatory inspections and client audits, including crafting responses that successfully addressed findings.

• Familiarity with internal audit programs, supplier quality initiatives, and/or GMP training programs.

• Preferred: Advanced degree (MS or PhD) in a scientific field.

• Preferred: Familiarity with ISO 9001 and/or ISO/IEC 17025.

• Preferred: Experience in computerized system validation (GAMP 5) and in highly automated or software-driven laboratory operations.

• Preferred: Working knowledge of software development, including 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 varying quality requirements.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with employer match.

• Opportunities for professional development and continuing education.

• Flexible work environment and work-life balance initiatives.