QMS Global Director
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Responsibilities
- Define, lead, and govern the global QMS operating model, including enterprise-wide standards, processes, governance mechanisms, decision rights, and deployment expectations across Global, Regional, and Site Quality organizations.
- Drive global QMS strategy, harmonization, and modernization initiatives, including simplification, digital enablement, standardization, scalability, and integration to support growth and acquisitions.
- Ensure QMS processes, procedures, documentation, and execution remain aligned with applicable regulatory requirements, industry standards, audit expectations, and business objectives.
- Provide enterprise oversight for key QMS processes, including 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 through robust global QMS design and consistent execution.
- Partner cross-functionally with Quality, Regulatory Affairs, Manufacturing, Operations, R&D, Supply Chain, and other stakeholders to promote operational excellence, accountability, and a strong culture of quality.
- Job 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, including 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 such as 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 environments.
- Strong executive communication, stakeholder management, and influencing skills, with the ability to communicate risk, trade-offs, recommendations, and quality system priorities to senior leaders across regions and functions.
Benefits
Additional Information
It's fun to work in a company where people truly believe in what they are doing! As Global Director, Quality Management Systems (QMS), you will lead the enterprise-wide strategy, governance, and continuous improvement of global quality systems across regions and sites. Reporting to the VP of Global Quality, this Director-level role serves as the global QMS Center of Excellence leader and trusted advisor to senior leadership on quality system maturity, compliance, risk, and operational capability. This is an opportunity to shape a scalable, standardized, and future-ready QMS in a highly regulated global environment.
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Company Intel
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