Machelle Eppler is a senior GMP, Quality, Compliance, and Regulatory executive with over 30 years of global experience in the pharmaceutical, biopharmaceutical, advanced therapies, and CDMO sectors. She has held leadership roles at Genentech, Roche, and Thermo Fisher, and brings deep expertise across the product lifecycle — from development to commercialization. Based in California with international experience in Europe and Asia-Pacific, Machelle is known for driving regulatory success, building strong quality cultures, and leading operational transformation for both large and emerging biopharma companies.

Machelle blends deep technical expertise with strategic foresight, enabling businesses to scale operations, navigate complex regulatory landscapes, and achieve sustainable quality outcomes. She is a trusted advisor with deep global experience in driving quality, compliance, and regulatory excellence across the product lifecycle. She has led strategic initiatives in inspection readiness, digital transformation, data integrity, laboratory productivity and operational efficiency, delivering multimillion-dollar savings and compliance.

She’s supported growth and expansion of multiple facilities and greenfield sites to deliver emerging modalities such as cell and gene therapy, mRNA, and viral vectors. She has co-led multiple M&A due diligence assessments and subsequent integrations. She has implemented harmonized global quality systems, KPIs, built strong regulatory inspection records, and championed Quality cultural transformation.