Katherine Mercier
Senior Quality & CMC Leader | Inspection-Ready GxP Systems | Late-Stage Clinical → Commercial Launch
- Role
- Fractional COO at Tidewave Bio
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Katherine Mercier
Strategic biopharmaceutical Quality & Technical Operations leader with 20+ years of global experience guiding companies through late-stage development, first product approvals, and commercial scale-up.I partner with biotech and pharma teams at critical inflection points — when Phase 2/3 programs advance toward registration, commercial execution begins, and regulatory expectations intensify. My focus is helping organizations build inspection-ready, scalable Quality and Tech Ops systems that support both the marketed product and a growing pipeline without overextending internal teams.I’ve led and advised cross-functional organizations through regulatory inspections, Quality remediation, PPQ and validation, CDMO oversight, and product launches across clinical and commercial manufacturing environments, including successful FDA and EMA inspections.How I typically support late-stage teams:• Inspection readiness and post-approval Quality operations• Pragmatic QMS scale-up aligned to Phase 3 and commercial needs• CDMO oversight, tech transfer, and supplier Quality governance• PPQ, process validation strategy, and launch readiness• Targeted remediation and interim leadership support during growthBased in San Diego, I work closely with local biotech teams and global partners, offering both consulting and fractional leadership support for organizations preparing for registration, launch, or ongoing commercial operations.If you’re navigating late-stage development, first approval, or post-approval scale-up, I’m always open to a peer-level conversation.
Experience
Fractional COO
Dec 2025 — Present
Fractional COO for an early-stage cell therapy company, providing strategic leadership across CMC development, regulatory pathway planning, and business operations, including support with fundraising execution and CDMO engagement.
Education
Université de Sherbrooke
B.S. Chemical Engineering
Skills
- Capa
- Biopharmaceuticals
- Quality Control
- Gmp
- Gxp
- Aseptic Processing
- Gamp
- Biotechnology
- Cross-Functional Team Leadership
- Quality System
- V&V
- 21 Cfr Part 11
- Process Simulation
- Glp
- Process Improvement
- Validation
- Quality Assurance
- Project Management
- Manufacturing
- Pharmaceutical Industry
- Sop
- Fda
- Computer System Validation
- Change Control
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