I am a QA/QMS consultant with over 22 years of experience in GMP biotech and pharmaceutical environments, supporting companies to design, remediate, and scale inspection-ready Quality Management Systems. My expertise spans sterile and aseptic operations, Annex 1 readiness, audit and inspection leadership, and end-to-end lifecycle quality from deviations and CAPA to validation and product release. I lead pragmatic, risk-based quality programs, serve as fractional Head of QA, and drive measurable outcomes across multi-site deployments, regulatory readiness initiatives, and complex manufacturing and supply chain environments.
REGULATORY & COMPLIANCE CONSULTANT
Mario Ignacio Ami
I am a QA/QMS consultant with over 22 years in GMP biotech and pharmaceutical environments. I specialize in building inspection-ready quality systems, Annex 1 sterile operations, audit readiness, and validation strategy. I support multi-site programs as a fractional Head of QA, driving risk-based compliance, operational stability, and measurable quality improvements.
Pharma & Biotech Consultant
LinkedIn profileAreas of expertise
- Quality management systems (QMS) design & remediation
- GMP audit & inspection readiness (FDA, EMA, TGA, PIC/S)
- Sterile & aseptic operations (Annex 1 compliance)
- Validation strategy, deviations, CAPA & change control
