Geneva Metropolitan Area
EXECUTIVE SUMMARY Global Quality & Operations Executive with 24+ years of experience leading multinational GMP organizations across Biotech, Pharma, and Global Health. Proven track record in building global quality functions, leading regulatory inspections, managing multi-site operations and P&L up to USD 20M, and partnering with Boards and Executive Committees to enable compliant growth and business transformation CORE COMPETENCIES Executive Leadership & Organizational Design | Strategy Execution & Governance | Regulatory & Business Risk Oversight | Quality Governance & QMS Leadership | Inspection Readiness & Health Authority Interface | Crisis Management | Global Operations & External Manufacturing Oversight | Financial Stewardship & P&L Accountability | Annex 1 & Sterile Manufacturing | Responsible Person | Stakeholder Management
• Built and scaled a 25-FTE Quality organization to support the successful launch of a new GMP mammalian drug substance site, enabling regulatory approval and manufacturing readiness. • Designed and deployed a robust QMS, including SOP governance, deviations, CAPA, change control, and quality KPIs • Led initial and routine regulatory inspections (Swissmedic), ensuring sustained inspection readiness • End-to-end QA oversight: manufacturing, raw materials, analytical, microbiology, equipment, facilities, and batch disposition. Led Annex 1 implementation for operations • Integrated Cell Line Development Quality • Provided quality oversight for an analytical GMP site in Belgium, securing GMP certificate renewal • Developed and embedded a strong Quality Culture across sites • Managed quality activities with external partners
• Full P&L accountability for 5 healthcare sites (80 employees, ~600 patients/day) • Built and deployed operational processes across Operations, HR, Finance, IT, Procurement, Quality & HSE • Led greenfield development of a new radiology center • Ensured regulatory compliance, radioprotection, and patient safety • Negotiated strategic contracts (equipment, leasing, maintenance) • Led digital transformation initiatives including online booking platforms • Acted as primary liaison with shareholders and board members
• Global leadership role combining Operations, Strategy and Governance with an annual budget of USD 20M • Defined and executed the Global Health strategy and governance • Managed partnerships, contracts, and donor relationships • Conducted compliance reviews and coordinated internal financial audits • Ensured alignment with clinical development programs • CEO Award for cross-functional collaboration and leadership
• Member of the Global Healthcare Quality Senior Leadership Team (1100 employees, 15 sites worldwide) • Defined and implemented the external quality strategy and global KPIs • Built and led a global organization of 45 quality professionals • Oversight of ~1700 suppliers (API, excipients, components, medical devices) • Led for-cause audits, regulatory escalations, and major quality events • Conducted Top 10 product risk assessments and reduced risk through dual-sourcing strategies
• Founded a consulting firm providing GMP, QMS, and regulatory compliance expertise to life-science companies