Quality System Manager

🕒 Yesterday

🦌 Connecticut – Remote

🦌 Connecticut – Remote

💵 $86k - $130k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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The Jackson Laboratory

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1929

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

The Jackson Laboratory is a nonprofit biomedical research organization that develops and distributes genetically defined mouse models, cell and computational resources, and preclinical services to accelerate biomedical discovery and translation to the clinic. It provides research platforms, data-science tools, custom model generation, and training and education programs for scientists, clinicians, and students, and partners with industry and academic groups to enable personalized medicine and drug development. JAX combines laboratory research, core services, and education to bridge mouse and human data and support advances in genetics and disease biology.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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