Remote VP of Quality & Regulatory Excellence

Sabin Vaccine Institute, Inc.; Northern (KY); Remote; USD 189,000 - 315,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Flexible vacation leave

401(k) plan with match

Equal Opportunity Employer

Job summary

Sabin Vaccine Institute, Inc. is seeking a Vice President of Quality to provide strategic leadership for GxP quality across GMP, GCP, GVP, and GLP. This role builds a phase-appropriate QMS for a virtual nonprofit and ensures program compliance, risk management, and inspection readiness as vaccines advance.

You will lead a global network of CROs, CDMOs, and labs, reporting to R&D leadership. The VP establishes quality governance, sponsor oversight, and governance forums.

Qualifications

• Leadership experience in biotechnology/virtual organizations.
• Proven success building or transforming a QMS for late-stage development.
• Direct experience supporting PPQ, PAI readiness, and BLA/MAA submissions.
• Knowledge of GMP, GCP, GLP, GVP requirements and ICH guidelines.

Responsibilities

• Lead QMS strategy across GMP, GCP, GVP, and GLP for vaccines.
• Advise executives on quality, compliance, inspection readiness, and risk management.
• Embed quality culture across functions and external partners.
• Oversee governance, metrics, escalation, and CAPA programs.
• Manage sponsor oversight for CDMOs, CROs, labs, and suppliers.
• Ensure documentation and data governance, inspection readiness, and data integrity.

Skills

Leadership

Quality management

GMP/GCP/GVP/GLP

Vendor oversight

Regulatory inspections

Education

Bachelor's degree in life sciences/quality

Job description

Sabin Vaccine Institute, Inc. is seeking a Vice President of Quality to provide strategic leadership for GxP quality across GMP, GCP, GVP, and GLP. This role builds a phase-appropriate QMS for a virtual nonprofit and ensures program compliance, risk management, and inspection readiness as vaccines advance.

You will lead a global network of CROs, CDMOs, and labs, reporting to R&D leadership. The VP establishes quality governance, sponsor oversight, and governance forums.