10/25/2026 updated
100 % available
⭐️⭐️⭐️⭐️⭐️ Quality Management | Process Excellence & Auditing | Compliance Officer
Prague, Czech Republic
Worldwide
Master in Microbiologist and Clinical Laboratory, Universidad del Valle, Cali, Colombia (2010)About me
Strategic Quality Leader with 10+ years in pharma, life sciences, and food. Expert in scalable QMS, global audits, and regulatory compliance. Proven success in EMA, MHRA, and NCA inspections. Skilled in team leadership, change management, and operational excellence across multi-site organizations.
ISO 27001Audit ManagementAudit PlanningISO 9000Management and Business ConsultingCapacity ManagementQuality AuditingCertified Regulatory Compliance ManagerPharmacovigilanceISO 22000ISO 13485 StandardManagement Control SystemsQuality ManagementNon-conformance ManagementSoftware Quality Management (Software Quality)
QMS Implementation & ISO Certifications
Expertise in building and leading scalable Quality Management System frameworks compliant with ISO 9001, ISO 22000, ISO 13485, ISO 27001, and HACCP standards. Certified Lead Auditor with hands-on experience implementing and maintaining these certifications across multi-site organizations.
GxP Compliance & Regulatory Inspections
Proven track record in successfully passing EMA, MHRA, and NCA inspections. Deep knowledge of GxP compliance, EU MDR readiness, and regulatory frameworks for pharma, life sciences, medical devices, and food industries.
Risk Management & CAPA Leadership
Strong background in risk management, non-conformity handling, and CAPA leadership. Experience in process validation, audit strategy, and risk-based audit planning to improve oversight of global operations and reduce compliance cycle times.
Global Audit Strategy & Supplier Quality Oversight
Direction of global client and internal audits with zero critical findings. Development of annual company audit strategies and execution of internal and vendor audits, including overall third-party management processes.
GDPR & Anti-Bribery Compliance Programs
Development and rollout of ISO 37001 Anti-Bribery and GDPR compliance programs. Leadership of company-wide training on ethical conduct, GDPR principles, and ABAC, achieving measurable compliance maturity and 100% staff and vendor participation.
AI and Automation in Quality & Compliance
Subject matter expertise in AI integration, automation initiatives, and process improvements within quality and compliance environments, contributing to reduced compliance cycle times and enhanced operational efficiency.
Post Market Surveillance & Medical Devices
Support of clients with Quality Management System and Post Market Surveillance System frameworks, cross-regional collaboration including US and EU regulatory review and approval processes.
Management, Leadership, Training & Team Development
Building, managing and mentoring quality and compliance teams from the ground up. Expansion of team capabilities, enhancement of KPI performance, and fostering a culture of continuous improvement across multi-site and cross-departmental organizations.
Experience
Professional experience10+ years
Freelancer since2025
Languages
EnglishFluentSpanishNative speakerCzechGood
Project history
Appointed to lead the newly centralised Product Quality Management organisation in the EMEA region. Built the team and operating model from the ground up. Led and trained a new Tier specialists team covering Product Quality complaints for the whole EMEA region. Worked with the Medical device US based team supporting the EU regulatory review and approval of medical devices. Designed and implemented operational strategies to align the region with cross-departmental stakeholders and global processes. Delivered a fully operational team with sustained metrics and KPIs after transition.
Led company-wide QMS strategy ensuring compliance with ISO 9001 and regulatory standards, including documentation, non-conformities (CAPAs), audits, change management, training, third-party management and validation processes. Directed global audits with zero critical findings. Acted as SME for risk management, AI integration, validation projects, and automation initiatives. Built annual audit strategy and implemented risk-based audit planning. Supported Medical Devices clients with QMS and Post Market Surveillance System frameworks. Implemented and maintained ISO 9001 and ISO 27001 certifications.
Developed and rolled out ISO 37001 Anti-Bribery and GDPR compliance programs, achieving measurable compliance maturity. Led company-wide training on ethical conduct, GDPR principles, and ABAC, ensuring 100% participation from staff and vendors.
Certificates
Auditing Computerised Systems
RQA2024
ISO/IEC 27001:2022 Implementation Workshop
AMTIVO2024
ISO 9001
RQA2019