Greater Milan Metropolitan Area
Pharmaceutical Qualified Person (AIFA) and Site Quality Head with over 20 years of experience in sterile manufacturing, biologics and ATMP environments within global pharmaceutical and CDMO organizations (Pfizer, Hospira, Thermo Fisher Scientific). Since February 2026, I serve as Site Quality Head for the mRNA Business Unit at Thermo Fisher Scientific (Monza site), accountable for the overall Quality strategy, compliance and performance of site operations dedicated to ATMP manufacturing. I lead a Quality organization of approximately 50 professionals across QA and QC functions, with direct reports including the QC Manager, QA Manager, Regulatory Affairs Liaison and Quality Systems Supervisor. My scope of responsibility includes: End-to-end Quality oversight of mRNA drug substance and drug product manufacturing Regulatory inspection readiness (FDA, EMA and international authorities) Customer audits and Health Authority inspections QP release and batch certification Quality Systems governance and continuous improvement Risk management, deviation and change control strategy I am a strong advocate of structured problem solving and continuous improvement, certified Lean Six Sigma Green Belt and TapRoot® practitioner. Previously within Thermo Fisher Scientific, I held leadership roles in Operational Excellence (Root Cause Analysis Expert) and GMP Documentation & Vendor Management, driving Quality System digitalization, lean transformation initiatives and supporting more than 70 customer and regulatory inspections. Earlier in my career, I served as Quality Assurance Manager at Lisapharma, where I redesigned and strengthened the Quality System leading to ISO 9001 and ISO 13485 certifications and FDA approval. I also spent over 12 years at Hospira (later Pfizer), covering roles of increasing responsibility within Quality Assurance. Over the years, I have developed a balanced expertise across three key dimensions: regulatory compliance and inspection readiness, operational Quality in sterile and ATMP manufacturing environments, and structured continuous improvement through Lean and Root Cause Analysis methodologies. Degree in Biotechnology (Università degli Studi di Milano). Member of the Italian Register of Biologists. Specialties: Quality Leadership, ATMP & mRNA Manufacturing, GMP Compliance, Regulatory Inspections, QP Release, Root Cause Analysis, Lean Six Sigma, Quality Systems Governance, Sterile & Aseptic Manufacturing.
Appointed as Site Quality Head for the mRNA Business Unit, accountable for the overall Quality strategy, compliance and performance of the site operations dedicated to ATMP manufacturing. I lead a Quality organization of approximately 50+ professionals across QA and QC functions. I am responsible for: - End-to-end Quality oversight of mRNA drug substance and drug product manufacturing - Regulatory inspection readiness (FDA, EMA and international authorities) - Customer audits and strategic Quality governance - Batch certification and QP responsibilities - Quality System effectiveness and continuous improvement - Risk management and compliance strategy Member of Site Leadership Team, contributing to operational and strategic decisions impacting manufacturing performance, regulatory positioning and business continuity.
Quality Assurance Manager for the mRNA (ATMP) Business Unit, leading QA and QC oversight activities within a newly established and rapidly scaling manufacturing environment. I managed a cross-functional Quality organization responsible for batch record review, deviation management and quality oversight of drug substance and drug product operations. In this role, I: - Led the QA organization during the operational ramp-up of the mRNA unit, supporting production growth from 8 batches in 2024 to 34 batches in 2025 - Ensured continuous inspection readiness in a highly innovative ATMP environment - Acted as primary liaison during Customer and Regulatory Agencies inspections - Oversaw deviation and change control systems aligned with increasing production complexity and regulatory expectations - Strengthened risk management and compliance governance during a critical expansion phase
Root Cause Analysis Expert within the Operational Excellence (PPI – Practical Process Improvement) Group, supporting site-wide Quality and Operations performance improvement initiatives. I led cross-functional investigations on complex GMP deviations, process inefficiencies and adverse trends, partnering closely with Operations and Site Leadership Team. In this role, I: - Applied structured methodologies (DMAIC, TapRoot®) to identify true root causes and implement sustainable CAPAs -Drove measurable improvements in Right First Time and deviation recurrence reduction -Strengthened a data-driven decision-making culture across departments -Mentored teams in problem-solving and Lean principles to enhance accountability and operational excellence This role enhanced my capability to operate at system level, influencing organizational performance beyond functional boundaries.
Supervisor within the QA / Quality Systems & Compliance department, leading three teams responsible for GMP documentation governance, Master Batch Records and Vendor Quality Management. I strengthened core Quality System processes in a complex CDMO environment, ensuring compliance, inspection readiness and operational robustness. Key contributions included: -Leadership of internal audit program and structured CAPA management -Governance of SOP lifecycle and documentation digitalization initiatives -Oversight of Master Batch Record issuance supporting sterile manufacturing -Supplier qualification and audit program aligned with global GMP expectations -Management and coordination of 70+ Customer and Regulatory inspections, ensuring effective preparation and post-audit remediation Actively contributed to Corporate Standards gap assessments and Quality Management Review processes, supporting continuous improvement of site compliance framework.
Quality Assurance Manager accountable for full plant Quality System governance within a small pharmaceutical manufacturing organization. I led a comprehensive redesign and reinforcement of the Quality System, driving the site toward international compliance standards and regulatory recognition. Major achievements included: -Achievement of ISO 9001 and ISO 13485 certifications -Successful FDA approval of the manufacturing site -Strengthening of deviation, change control and complaint management processes -Introduction of structured Quality Metrics and PQR governance -Leadership of Customer and Regulatory inspections This experience allowed me to build and consolidate a Quality culture in a growing organization, balancing compliance rigor with operational sustainability.
Quality Operations Manager within the QA department, leading Manufacturing Quality Assurance (MQA) and Quality Systems (QS) teams in a sterile manufacturing environment. I was responsible for ensuring GMP compliance across day-to-day manufacturing operations, strengthening Quality oversight on the shop floor and reinforcing Quality System effectiveness. Key responsibilities and impact included: -Leadership of MQA (Quality on the floor) and QS teams supporting aseptic manufacturing operations -Oversight of deviations, laboratory investigations, complaints and Quality Metrics governance -Supervision of media fill programs and facility GMP compliance monitoring -Management of Customer and Regulatory inspections, ensuring structured audit preparation and CAPA execution -Active contribution to Quality Management Review processes and site performance monitoring This role consolidated my operational Quality leadership experience within a complex sterile injectable manufacturing environment
Primary Quality liaison for strategic customers, managing Quality Agreements, customer requests and GMP compliance requirements across multiple markets. Supported cross-functional coordination and performance monitoring through defined metrics and review processes.
Responsible for supplier qualification, technical agreements and audit activities. Contributed to packaging quality oversight and lean manufacturing initiatives within the Packaging department.
Managed raw material and packaging material quality control activities including sampling, NIR analysis and supplier qualification support.