Global QMS Director

🕒 3 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Neogen Corporation

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🧬 Biotecnologia

🌾 Agricultura

🍽️ Alimentos e Bebidas

Biotechnology • Agriculture • Food & Beverage

As soluções da Neogen® podem ser encontradas em cada etapa da cadeia alimentar.

Descrição

• Define, lead, and govern the global QMS operating model, including standards, processes, governance mechanisms, decision rights, and deployment expectations • Drive global QMS strategy, harmonization, and modernization, including simplification, digital enablement, standardization, scalability, and integration supporting growth and acquisitions • Ensure QMS processes, procedures, documentation, and execution align with regulatory requirements, industry standards, audit expectations, and business objectives • Provide enterprise oversight for CAPA, change control, document control, deviation management, risk management, training, and quality performance metrics • Lead systemic audit readiness and support regulatory inspections, third-party audits, and internal audits • Partner with Quality, Regulatory Affairs, Manufacturing, Operations, R&D, Supply Chain, and other stakeholders to promote operational excellence, accountability, and a culture of quality • Report to the VP of Global Quality • Serve as the global QMS Center of Excellence leader and trusted advisor to senior leadership

🎯 Requisitos

• Bachelor's degree in Quality, Engineering, Life Sciences, Biology, Regulatory Affairs, or a related field • Advanced degree such as an MBA, MS, or equivalent is preferred • 10+ years of experience in Quality Management Systems, quality assurance, regulatory compliance, or regulated manufacturing environments • Demonstrated experience leading global or enterprise-wide QMS harmonization • 7+ years of leadership experience managing global or enterprise-level Quality or QMS teams in a complex, matrixed organization • Expert-level knowledge of global QMS design, governance, deployment, lifecycle management, and regulatory frameworks • Knowledge of FDA, ISO 9001, ISO 13485, ISO 17025, GMPs, HACCP, and comparable international standards • Experience in regulated industries such as animal health, diagnostics, food safety, pharmaceutical, biotech, medical device, or regulated manufacturing • Strong executive communication, stakeholder management, and influencing skills • Ability to communicate risk, trade-offs, recommendations, and quality system priorities to senior leaders across regions and functions

🏖️ Benefícios

• A standard benefits package designed to support employee well-being • Inclusive, professional work environment • Opportunity to influence enterprise quality strategy, governance, and operational excellence • Opportunity to lead QMS transformation, modernization, and harmonization initiatives • Collaboration with senior leaders and cross-functional teams across global business areas