Global QMS Director

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Neogen Corporation

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

🌾 Agriculture

🍽️ Food & Beverage

Biotechnology • Agriculture • Food & Beverage

Neogen Corporation is a biotechnology company that offers a comprehensive range of solutions and services aimed at ensuring food safety throughout the food chain. They cater specifically to the food processing, animal protein, and agriculture industries, helping to protect the global food supply while promoting efficient production practices. In addition to their primary focus on food safety, Neogen also serves the companion and performance animal sectors, as well as engaging in life sciences and toxicology fields.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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