Quality System Manager

🕒 vor 1 Tag

🦌 Connecticut – Remote

🦌 Connecticut – Remote

💵 $85.987 - $130.000 / Jahr

⏰ Vollzeit

🟠 Senior

🔴 Experte

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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The Jackson Laboratory

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 1929

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Das Jackson Laboratory ist eine gemeinnützige biomedizinische Forschungseinrichtung, die genetisch definierte Mausmodelle, Zell- und Rechenressourcen sowie präklinische Dienstleistungen entwickelt und vertreibt, um biomedizinische Entdeckungen und die Übersetzung in die Klinik zu beschleunigen. Es bietet Forschungsplattformen, Datenwissenschaftswerkzeuge, maßgeschneiderte Modellerstellung sowie Schulungs- und Bildungsprogramme für Wissenschaftler, Kliniker und Studierende an und kooperiert mit Industrie- und akademischen Gruppen, um personalisierte Medizin und Arzneimittelentwicklung zu ermöglichen. JAX kombiniert Laborforschung, grundlegende Dienstleistungen und Bildung, um Maus- und menschliche Daten zu verknüpfen und Fortschritte in der Genetik und Krankheitsbiologie zu unterstützen.

Beschreibung

• Direct efforts to harmonize quality practices across all JAX locations, domestically and internationally where applicable • Develop and execute JAX-wide strategies to enhance process efficiency and improve risk mitigation • Oversee internal and external audits, deviation reviews, CAPA facilitation, document control, and change management • Train and lead the Quality team in industry best practices • Reshape quality culture across the global organization • Develop a long-term process development and improvement strategy in collaboration with the global organization • Identify, analyze, and leverage quality data to identify trends and risks • Manage risk-based assessments and support risk mitigation strategies • Implement continuous quality improvements to reduce complexity and improve effectiveness, efficiency, productivity, sustainability, and globalization • Develop and implement organization-wide quality process development and improvement policies • Provide strategic leadership in policy setting • Determine and implement the quality assurance/quality system subset strategy for the global team • Co-lead implementation of quality and regulatory compliance software systems • Direct quality personnel through coaching, counseling, and employee leadership • Maintain professional and technical knowledge • Perform other duties as assigned

🎯 Anforderungen

• Bachelor's degree and 7 years of relevant quality experience • Minimum of 2 years supervisory experience • Expertise in risk management tools, including Design FMEA and Process FMEA (pFMEA) • Proficiency in Root Cause Analysis (RCA), statistical analysis, and data-driven decision-making • Experience with MSA/Gauge R&R, quality metrics, and performance monitoring • Experience with and knowledge of ISO 9001 standards • Knowledge of Computer System Validation requirements • Strong knowledge of Quality by Design (QbD) principles and stage-gate product development • Functional management/leadership experience in a pharmaceutical or biotechnology operation • Experience with change management in a multi-site, complex environment • Advanced interpersonal skills for developing complex relationships across cultures, disciplines, and organizational levels • Advanced verbal and written communication skills for communicating with senior leaders • Ability to formulate, analyze, and evaluate complex plans and programs • Ability to keep current on industry practices, regulatory requirements, and industry changes • Ability to travel 10% • Lean/Six Sigma certification preferred • Quality certifications such as CQA or CQM/OE are a plus • Research regulatory compliance experience preferred

🏖️ Vorteile

• Remote work arrangement • Professional development through educational workshops, professional publications, personal networks, and professional societies • Equal employment opportunities