Manuel Miranda
@manuelmiranda
Senior quality & compliance audit lead with 10+ years driving GxP compliance, risk-based audits, and continuous improvement.
MexicoWhat I'm looking for
I’m a Senior Quality and Compliance professional with 10+ years of experience in regulated environments, specializing in GxP auditing, internal controls, regulatory compliance, and quality systems. I lead risk-based audits end-to-end, ensuring alignment between processes, controls, and regulatory requirements.
I’ve led 200+ internal, external, and regulatory audits across manufacturing and operational environments, achieving >90% compliance rates across multiple facilities. I supported regulatory inspections (COFEPRIS) with zero critical findings, and I developed structured audit reporting frameworks that improved clarity, traceability, and corrective action effectiveness.
I also designed and implemented full Quality Management Systems (QMS) including CAPA, deviations, and change control. Known for critical thinking in complex audit scenarios, I evaluate CAPA effectiveness, manage audit observation closure, and train cross-functional teams so compliance becomes a sustainable operating model.
Experience
Work history, roles, and key accomplishments
Quality & Regulatory Compliance
Independent
Nov 2025 - Present (7 months)
Provide strategic consulting in Quality Management Systems (QMS), Regulatory Compliance, GMP, COFEPRIS product registrations, Internal Audits, CAPA, Risk Management, and Continuous Improvement. Advise pharmaceutical and medical device companies on regulatory strategy, quality systems, and inspection readiness.
Senior Quality & Audit Manager
CADERSO
Aug 2022 - Nov 2025 (3 years 3 months)
Planned and conducted internal and external audits across pharmaceutical facilities, ensuring compliance with SOPs, regulatory requirements, and operational standards.
Performed risk-based audits, evaluating process controls, documentation, and operational execution.
Wrote and issued clear audit reports, identifying findings, root causes, and actionable CAPA recommendations.
Pharma Development Project Mgr
ESIC Pharma
Apr 2019 - Mar 2022 (2 years 11 months)
Led cross-functional pharmaceutical development projects to ensure compliance across development, sourcing, and regulatory submission activities. Managed audit-related documentation review and corrective actions, and coordinated global stakeholders to maintain multi-site compliance.
Quality Assurance & Deputy
ESIC Pharma
Aug 2013 - Apr 2019 (5 years 8 months)
Designed and implemented a Quality Management System (QMS) including CAPA, deviations, change control, and audits to strengthen manufacturing compliance. Led 80+ internal, supplier, and regulatory audits, and directed investigations for non-conforming products through containment, root cause analysis, and corrective actions.
Education
Degrees, certifications, and relevant coursework
Instituto Tecnológico y de Estudios Superiores de Occidente (ITESO)
Bachelor of Chemical Engineering, Chemical Engineering
Earned a Bachelor of Chemical Engineering at ITESO. Education focused on chemical engineering fundamentals and preparation for regulated industry work.
Tech stack
Software and tools used professionally
Availability
Location
MexicoAuthorized to work in
Social media
Job categories
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