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Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

People Leader

All Job Posting Locations:

Huejotzingo, Puebla, Mexico

Job Description:

Position Summary

Quality Assurance / Quality Systems Manager lead and continuously improve the Quality Management System (QMS). This role combines strategic ownership of quality systems (e.g., eQMS, CAPA, change control, document control) with hands-on operational oversight of compliance, audits, supplier quality, and product release activities. The ideal candidate is a systems thinker who partners cross-functionally to reduce risk, increase product and process robustness, and embed a culture of quality.

Key Responsibilities

• Own, maintain, and continuously improve the Quality Management System to meet internal requirements and applicable regulatory standards (e.g., ISO 9001, ISO 13485, 21 CFR Part 820, GMP, or industry-specific standards as relevant).
• Lead the administration and optimization of digital QMS tools: document management, CAPA, nonconformance, change control, training, audit management, and supplier quality modules.
• Manage CAPA lifecycle: root cause analysis, corrective actions, validation of effectiveness, and closure with evidence-based controls.
• Oversee product release, lot disposition, and quality review processes; ensure timely and compliant product commercialization.
• Lead supplier quality activities: qualification, monitoring, performance metrics, and remediation plans.
• Drive change control and risk management processes; perform or review risk assessments (e.g., FMEA, risk registers) and ensure mitigation actions are implemented.
• Establish and report meaningful quality KPIs and dashboards (e.g., CAPA cycle time, audit findings trend, supplier PPM, customer complaints, deviation rates).
• Provide leadership, coaching, and training on QA processes and QMS usage to cross-functional teams.
• Maintain document control: policies, SOPs, batch records, specifications, and quality records with current revision control.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field; advanced degree preferred. Pharmaceutical:  Chemist-Biologist, Pharmaceutical Engineer or Industrial Pharmaceutical Chemist.
• 8+ years of progressive quality systems experience; or 5+ years in managerial role ( medical devices, pharma, biotech, CPG, manufacturing).
• Business English proficiency.

Preferred

• Certification: ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
• Experience with Lean, Six Sigma (Green/Black Belt), or other continuous improvement methodologies.
• Experience in supplier audits and vendor management, including international suppliers.
• Prior experience in regulatory inspection readiness and successful management of regulatory responses.

Core Competencies & Skills

• Leadership: ability to influence without authority; coach teams to adopt quality practices.
• Communication: clear written and verbal communication for technical and non-technical audiences; able to write concise CAPA reports and audit responses.
• Project management: ability to manage multiple projects, prioritize, and meet deadlines.
• Attention to detail and organizational discipline.
• Problem solving: structured and evidence-based approach to troubleshooting and preventive action.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Analytics Dashboards, Collaboration, Compliance Management, Data Gathering and Analysis, Data Quality, Incident Management, Performance Measurement, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Technical Credibility