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Michele M. Status: Offline
Bern, Switzerland
100% Job Success
Top Rated

Freelance Management Consultant

Visionary Life Sciences Leader with over 12 years of progressive experience in QA, QC, R&D, and program management. I have a proven track record of driving innovation and operational excellence in multinational environments across the US, Japan, UK, Europe, and Africa. My expertise includes navigating FDA, MHRA, EP, Swiss Medic, and JP regulations, as well as international standards like ICH, COSHH, and ISO. Throughout my career, I have been involved in CAPEX and OPEX projects, working across diverse industries from global corporations to start-ups, including Biotech, Pharma, Food, and CDMOs. My experience spans products such as ATMP, large and small molecules (e.g., API), and vaccines (mRNA, attenuated, and inactive), covering the entire lifecycle from raw materials to DS, DP, and fill-finish. Recently, I completed an Executive MBA in Healthcare Management and an Applied Data Science course. Currently, I am pursuing a CTO program to position myself for transformative leadership roles in Life Sciences. Key Strengths: 🌎 Global & Strategic Perspective: Leveraged international experience in five countries to lead cross-cultural teams and navigate complex regulatory landscapes successfully. 💡 Innovation Champion: Spearheaded technology transfers and QMS developments, driving operational efficiencies and quality improvements. 🔄 Change Management: Demonstrated ability to adapt and lead teams through evolving market dynamics and regulatory changes. Impact Across Various Domains: Advanced a gene therapy product from pre-clinical stage to phase 1 clinical trials. Successfully contributed to the submission of a IND application to the US FDA. Restructured the Technical Unit into work packages and Key Performance Indicators (KPIs). Managed a portfolio of 8 projects within QA, QC, and digitalization domains. Indirectly managed a team of up to 21 individuals across Switzerland, Denmark, and Sweden. Ensured mRNA vaccine QA batch release during the COVID-19 pandemic. Developed the VI/VA (Visual Inspection/Visual Appearance) method and process. Established the Quality (QC and QA) department, growing the team from 0 to 9 members. Developed and implemented Quality Management Systems (QMS), training, EM programs, and 3 stability studies. Conducted a multi-site stability investigation between Switzerland and Japan, aiming to increase API shelf life and company revenues. Developed a strategy and roadmap for the digitalization of clinical services in Nigeria. Created AI/ML algorithms for early and better detection of Plasmodium parasite cell infections.
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Skills

Skills

Get started working with Michele quickly with these predefined projects.

Get started working with Michele quickly with these predefined projects.

You will get innovation, strategy, digital transformation and business initiatives

From $2,500
30 days delivery

You will get write, review and translation of documents in English, German and Italian

From $1,500
15 days delivery

You will get stability, EM, PM, TT, Method, Equipment, QC, QA, GAP, RA services

From $2,500
30 days delivery

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