Machelle Eppler is a senior GxP Quality, Compliance, and Regulatory executive with over 30 years of experience across pharmaceuticals, biopharma, advanced therapies, and CDMOs, with deep expertise spanning development through commercialization. She has held leadership roles at Genentech/Roche and Thermo Fisher.

Based in California, with global experience across Europe and Asia-Pacific, Machelle is a trusted advisor to CEOs and Boards, delivering strategic quality and regulatory solutions that enable compliance, growth, and operational excellence. Known for driving regulatory success, she leads inspection readiness, remediation, and operational transformation initiatives.

She is recognized for stepping into high-stakes environments—preparing for pivotal inspections, remediating compliance challenges, integrating acquisitions, and scaling advanced therapy platforms—delivering rapid clarity, decisive action, and measurable outcomes that build compliant, resilient organizations and protect patients.

Machelle blends deep technical expertise with strategic foresight, enabling organizations to scale operations, navigate complex regulatory landscapes, and achieve sustainable quality outcomes. A trusted advisor with extensive global experience, she drives quality, compliance, and regulatory excellence across the full product lifecycle.

She has led global quality transformations, strengthening governance and embedding scalable, inspection-ready systems across diverse operating environments. Her experience includes advancing quality systems, inspection readiness, digital transformation, data integrity, laboratory productivity, and operational efficiency—delivering sustained compliance and significant cost savings.

Machelle has supported the growth and expansion of multiple facilities, including greenfield sites, to enable emerging modalities such as advanced therapies, vaccines and sterile products. She has also co-led M&A due diligence and post-acquisition integrations, implementing harmonized global quality systems, KPIs, and strong regulatory inspection records while championing quality culture transformation.

She is particularly recognized for stepping into high-stakes situations—providing clarity, direction, and execution during regulatory challenges, organizational change, and expansion. Partnering closely with executive teams, she aligns quality and regulatory strategy with business priorities to drive sustainable performance, operational excellence, and patient-focused outcomes.