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Directs the development and implementation of quality validation of equipment and systems to ensure compliance with appropriate regulatory agency requirements, internal firm standards and industry current practices. Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements.
The LATAM Quality Sr Manager is responsible for leading and overseeing quality assurance programs, compliance initiatives, and continuous improvement activities across the Latin America region. This role reports to the VP of Global Quality and provides regional oversight for all LATAM Quality teams and site Quality leaders. The LATAM region includes multiple manufacturing, laboratory, and distribution sites across Brazil, Mexico, and other Latin American countries.
This role ensures products, processes, and operations consistently meet company quality standards, customer expectations, and applicable regulatory requirements.
The ideal candidate will partner closely with manufacturing, operations, supply chain, commercial teams, and global quality leadership to drive a culture of quality, operational excellence, and compliance throughout the region. This role requires professional fluency in English, Spanish and Portuguese to effectively lead and support teams across the LATAM region and to be a leader on the Global Quality Leadership team.
Essential Duties and Responsibilities:
Regional Quality Leadership
Own and be accountable for regional quality performance, compliance risk, and operational readiness across all LATAM sites, including escalation of systemic issues to Global Quality leadership.
Serve as the primary regional point of accountability for major quality events, regulatory interactions, and business-impacting quality risks.
Exercise appropriate quality authority, including the ability to stop production, place product on hold, or delay release when quality or compliance risks are identified.
Lead regional response to critical quality incidents, including recalls, regulatory enforcement actions, and supply continuity risks, in coordination with Global Quality and Executive Leadership.
Lead deployment of Global Quality initiatives, standards, and transformation programs across LATAM, ensuring local adoption while providing structured feedback to Global Quality on regional risks, gaps, and improvement opportunities.
Contribute to Global Quality strategy development by bringing forward regional insights, risks, and improvement opportunities from LATAM operations.
Ensure alignment of regional quality practices with global quality standards and organizational objectives.
Drive a Quality culture focused on compliance, continuous improvement, and operational excellence.
Lead quality-related change initiatives across LATAM, including process standardization, system adoption, and cultural transformation efforts.
Drive change management activities to ensure sustained adoption of new quality processes, tools, and behaviors.
Provide leadership and support to regional quality teams and site quality leaders.
Quality Systems & Compliance
Ensure compliance with company policies, regulatory requirements, and applicable industry standards.
Maintain and improve quality management systems (QMS) across LATAM facilities and operations.
Support implementation and standardization of global quality procedures and best practices.
Own regional quality metrics, dashboards, and performance reviews; provide clear, data-driven insights and recommendations to Global Quality and regional leadership.
Monitor quality metrics and drive corrective and preventive actions as needed.
Provide regional oversight of supplier quality performance, including risk assessment, issue escalation, and collaboration with Global Supplier Quality and Supply Chain to mitigate quality and continuity risks.
Audit & Regulatory Management
Lead preparation and support for internal, external, customer, and regulatory audits.
Ensure audit readiness and timely resolution of audit findings.
Partner with Regulatory Affairs and Operations to maintain compliance with local and international regulations.
Support investigations related to quality concerns, non-conformances, and customer complaints.
Continuous Improvement
Identify opportunities to improve product quality, process efficiency, and operational performance.
Lead root cause analysis and corrective action initiatives.
Utilize quality data and trends to support decision-making and risk mitigation strategies.
Promote Lean, Six Sigma, and continuous improvement methodologies where applicable.
Cross-Functional Collaboration
Collaborate with Manufacturing, Supply Chain, R&D, Commercial, Technical Services, and Regulatory teams to support business objectives.
Serve as the regional Quality approver and escalation point for new product introductions, technology transfers, and major process changes impacting LATAM operations.
Partner with suppliers and external partners to ensure quality expectations are met.
Leadership & Talent Development
Coach, mentor, and develop quality team members across the LATAM region.
Foster employee engagement, accountability, and professional development.
Support succession planning and talent development initiatives.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Strong understanding of quality systems, compliance standards, and audit processes.
Experience working in highly regulated, multi-country LATAM environments.
Demonstrated experience leading through influence in matrixed organizations.
Strong communication and stakeholder management skills.
Experience within animal health, diagnostics, food safety, pharmaceutical, biotech, or manufacturing industries.
Education and Experience
Bachelor’s degree in Quality, Engineering, Biology, Microbiology, Animal Science, Food Science, Life Sciences, or related field.
10+ years of progressive experience in quality assurance, regulatory compliance, or manufacturing environments.
5+ years of leadership or people management experience.
Demonstrated experience working with major LATAM regulatory agencies (e.g., MAPA, ANVISA, SENASICA, COFEPRIS, SENASA, SAG, ICA, INVIMA) and global regulatory frameworks such as FDA.
Knowledge of ISO 9001, ISO 17025, and GMPs
Lean Six Sigma or ASQ certification preferred.
Fluency in English, Spanish and Portuguese required.
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