Gaelle S.

About Gaelle S.

With over 15 years in biopharmaceutical manufacturing, device operations, and combination product development, I deliver mission-critical execution across regulated environments from clinical through commercial launch. I specialize in guiding global CMOs, 3PLs, and supply networks under GMP, ISO 13485, FDA 21 CFR Part 820, and ICH standards, while building resilient operations that scale.I lead integrated operations of drug-device combination products, driving technology transfers, validation (PPQ/CPV), serialization (DSCSA), supplier oversight, and inspection readiness. I’m known for bridging cross-functional teams (Quality, Regulatory, Clinical, Commercial) to align operations with strategic business goals, embedding continuous improvement, and delivering cost / time efficiencies.Previously, I directed validation and compliance programs for medical device and pharma clients, strengthening inspection readiness and supporting global quality systems. My earlier experience includes roles in validation, where I honed a deep technical grounding in GMP and quality assurance.Core strengths include: CMC & device scaling, supply chain continuity & vendor management, quality systems / CAPA / audits, process validation, combination product regulations, continuous improvement, and risk mitigation.I’m passionate about driving operational excellence, advancing therapies to patients, and building teams that thrive in ambiguity. Let’s connect if you’re working at the intersection of biotech, device, and quality-driven operations.

Experience

1. Sr Director of Client Engagement

   Critical Mass Consulting, Llc

   Dec 2025 — Present · Los Angeles, CA, US

Education

• Collège Maisonneuve

  College Diploma Degree, Health Science

  2000 — 2003

• Université de Montréal

  Bachelor's degree, Chemistry

  2005 — 2008

Skills

• Ansm
• Validation
• Cleaning Validation
• 21 Cfr Part 11
• Medical Device
• Gmp
• Pharma Industry
• Change Control
• Trackwise
• QA
• Sop
• Fda
• Project Management
• Quality System
• Process Validation
• Glp
• Bpf
• Contrôle Des Modifications
• Lean Manufacturing