Quality Systems Manager
Há 2 dias
Brasil
Lever, Inc.
Remoto
Tempo integral
R$ 623.000 - R$ 697.000/ano
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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Systems Manager based in Brazil.
This is a corporate-level quality leadership role focused on maintaining and continuously improving a standardized Quality Management System across multiple facilities.
- Establish quality system requirements, strengthen governance, and help ensure consistent implementation across regulated operations.
- Use data and quality trends to identify systemic risks, drive corrective actions, and improve operational effectiveness.
- Work cross-functionally, partnering with Quality, Operations, Product, Regulatory, Supply Chain, and facility teams.
- Serve as the primary administrator and business owner for an electronic QMS, supporting adoption, workflows, data integrity, and reporting.
- Offer ownership and influence in a remote, high-trust environment focused on quality, compliance, and continuous improvement.
Accountabilities
- Own, implement, maintain, and continuously improve the corporate Quality Management System, establishing standardized processes, procedures, governance, and quality expectations across facilities.
- Provide guidance and support to facility Quality teams to ensure corporate requirements are consistently implemented while allowing for appropriate site-specific procedures.
- Manage the corporate Document Control program, including document creation, review, approval, issuance, revision, periodic review, archival, obsolescence, and controlled distribution.
- Lead the Change Control program, ensuring changes are documented, risk-assessed, reviewed, approved, implemented, communicated, and verified for effectiveness.
- Manage and support the Food Safety and Quality Training Program, including learning plans, training matrices, assignments, completion tracking, retraining requirements, and training records.
- Serve as the business owner and primary Quality administrator for Veeva QualityOne, supporting configuration, workflows, user adoption, data integrity, reporting, and continuous improvement.
- Develop, maintain, communicate, and support implementation of corporate Quality Standards, translating requirements into effective facility-level programs and procedures.
- Provide governance and workflow support for CAPAs, deviations, non-conformances, and OOS events, including investigation quality, root cause analysis, action planning, approvals, effectiveness checks, trending, and timely closure.
- Manage complaint trending and quality data analysis to identify recurring issues, emerging risks, systemic trends, and opportunities for corrective or preventive action.
- Support Management Reviews by compiling, analyzing, and presenting QMS performance indicators, CAPA and deviation status, complaint trends, audit observations, training performance, and other relevant quality metrics.
- Support internal, customer, regulatory, and certification audits by maintaining controlled, complete, current, and audit-ready QMS documentation and records.
- Partner with Quality, Operations, Product, Regulatory, Supply Chain, and other stakeholders to integrate quality requirements into business processes, new initiatives, and organizational changes.
- Monitor QMS effectiveness through metrics, trending, periodic reviews, and compliance assessments, recommending improvements based on risks, audit findings, recurring issues, and business needs.
- Provide training, coaching, and technical guidance to facility Quality teams and other stakeholders on QMS processes, documentation, QualityOne workflows, and applicable standards.
- Ensure corporate quality records are properly maintained, retained, protected, and readily retrievable in accordance with regulatory and company requirements.
- Drive harmonization and standardization across facilities while escalating significant compliance, product quality, or food safety risks to Quality leadership.
Requirements
- Demonstrated experience implementing, managing, and improving Quality Management Systems in a regulated food, dietary supplement, consumer health, or related environment.
- 5+ years of Quality Systems or Quality Assurance experience with a bachelor’s degree in Food Science, Quality, Biology, Chemistry, Engineering, or a related field, or an equivalent combination of education and relevant technical experience.
- Working knowledge of applicable FDA requirements, including 21 CFR Part 111, and current Good Manufacturing Practices (cGMPs).
- Experience with document control, change control, training systems, CAPA, deviations, OOS investigations, complaint trending, and quality metrics.
- Experience administering electronic Quality Management Systems, with Veeva Q