Brian Saxton

Vice President Quality Assurance at Stealth BioTherapeutics

Professional Overview

Brian Saxton is an accomplished pharmaceutical quality assurance executive with over 30 years of experience driving quality, compliance, and validation initiatives for leading biotech and pharmaceutical organizations. As the Vice President of Quality Assurance at Stealth BioTherapeutics, he is responsible for overseeing all quality systems, processes, and activities to ensure the highest standards of product quality, safety, and regulatory compliance.

Experience Summary

Current Role

As the Vice President of Quality Assurance at Stealth BioTherapeutics, Brian is accountable for the company's quality management system, including quality planning, quality control, and quality assurance. He leads a team of quality professionals to implement robust quality procedures, conduct internal audits, manage supplier quality, and ensure successful regulatory inspections. Under his leadership, Stealth BioTherapeutics has maintained an exemplary quality record and earned the trust of key stakeholders.

Career Progression

Brian has held progressive quality leadership roles within the pharmaceutical industry, including Executive Director and Senior Director of Quality Assurance at Stealth BioTherapeutics, as well as Senior Director and Director of Quality Assurance at TESARO, Inc. Prior to that, he served as a Principal Consultant at Compliance Risk Management, where he provided expert guidance on quality systems, validation, and compliance to various clients. Earlier in his career, Brian held quality management positions at Sunovion Pharmaceuticals, Acusphere, Integrated Project Services, and Bard Cardiology, among others.

Academic Background

Brian holds a Bachelor of Science degree in Mechanical Engineering from the University of Massachusetts Lowell. He is a seasoned quality professional with deep expertise in quality systems, cGMP compliance, process validation, and regulatory affairs.

Areas of Expertise

• Quality assurance and quality control

• Pharmaceutical manufacturing and operations

• Regulatory compliance (FDA, EMA, ICH)

• Validation and change management

• Quality system implementation and optimization

• Supplier quality management

• Leadership and team development

Professional Impact

Under Brian's quality leadership, Stealth BioTherapeutics has maintained a robust quality management system, ensuring the successful launch of its first commercial product and the seamless progression of its clinical pipeline. He has played a pivotal role in maintaining the company's strong regulatory standing and fostering a culture of quality excellence. Brian's extensive industry experience, technical expertise, and strategic vision have been instrumental in driving continuous improvement and supporting the organization's growth.

Conclusion

With his impressive track record of delivering quality excellence in the pharmaceutical industry, Brian Saxton is a seasoned quality assurance executive poised to drive continued success at Stealth BioTherapeutics. His unwavering commitment to quality, regulatory compliance, and operational efficiency make him a valuable asset to the organization as it navigates the complex and dynamic biotech landscape.