Vice President of Quality
Job Summary
Providing strategic and operational leadership for GxP quality, the fully remote Vice President of Quality will develop and sustain a comprehensive Quality Management System (QMS) while advising executive leadership on compliance, risk management, and inspection readiness for vaccine development and clinical trials.
Key responsibilities
- Develop and execute a roadmap for a mature QMS supporting GMP, GCP, GVP, and GLP for advanced development activities
- Serve as a strategic advisor on quality, compliance, and risk management to executive leadership
- Lead inspection readiness and act as the sponsor quality lead for health authority inspections
Required qualifications
- Bachelor's degree in a relevant scientific or engineering field with at least 16 years of quality experience in biologics development; an advanced degree is preferred
- Proven people-leadership experience and success in driving organizational change in a biotechnology or virtual organization
- Direct experience in late-stage clinical development, process validation, and regulatory submissions
- Expert knowledge of GMP, GCP, GLP, and GVP requirements and relevant ICH guidelines
- Experience establishing quality governance across outsourced development networks, including CDMOs and CROs
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