Jesse Ahrendt

About Jesse Ahrendt

Quality & Compliance Leader | Biotech | Pharma | Medical DevicesResults-driven quality and compliance executive with 25+ years of experience in biotech, pharmaceutical, and medical device industries. Proven expertise in building and leading high-performing quality teams, managing global compliance, and driving operational excellence across multi-facility and CDMO environments.Skilled in developing and executing strategic quality initiatives, remediation programs, and regulatory inspection readiness to enhance compliance, efficiency, and product release with lifecycle success. Adept at optimizing organizational resources, managing risk, and ensuring adherence to cGMP, FDA, EMA, and other global regulatory standards. Core Expertise: Quality Systems | cGMP Compliance | Regulatory Strategy | CAPA | Risk & Change Management | Process Optimization | Validation & Qualification | Supply Chain Quality | Manufacturing Compliance | Technical Writing | Data Integrity Let’s connect to discuss quality excellence, regulatory strategy, and industry best practices!

Experience

1. SVP Quality Assurance & Regulatory Affairs

   Antheia, Inc

   Jan 2023 — Present · Menlo Park, CA, US

   Driving global quality and compliance strategy for an innovative synthetic biology manufacturing company developing next-generation plant-derived medicines.Leading QA/RA for commercial fermentation-based pharmaceuticals, ensuring cGMP compliance across global operations. Develop and implement QMS to support tech transfer, manufacturing, validation, and regulatory expectations. Manage regulatory submissions (FDA, EMA, AIFA, DEA) and oversee QMS, document control, CAPA, supplier qualification, CMO management and product release to uphold quality excellence.

Education

• Eckerd College

  BSc, Biology

Skills

• Strategic Planning
• Customer Relations
• Cost Reduction
• Change Management
• Management Consulting
• Quality Assurance
• Medical Devices
• Quality Management
• Strategy
• Negotiation
• Pharmaceuticals
• Biotechnology
• Process Engineering
• Inventory Management
• Forecasting
• Continuous Improvement
• Compliance
• Cross-Functional Team Leadership
• Lean Manufacturing
• Budgets
• Customer Service
• Logistics
• New Business Development
• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Product Development
• Operations Optimization
• Business Strategy
• Contract Negotiation
• Start-Ups
• Team Building
• Manufacturing
• Program Management
• Validation
• Business Planning
• Operations Management
• Change Leadership
• Budgeting
• Risk Management