Remote VP Quality: GxP Strategy & Inspection Readiness

Sabin Vaccine Institute, Inc.; United States; À distance; USD 284 000 - 347 000; Plein temps

Résumé du poste

Sabin Vaccine Institute, Inc. is seeking a Vice President of Quality to provide strategic leadership for GxP quality across GMP, GCP, GVP, and GLP within a virtual nonprofit organization.

The role reports to the President of R&D and sits on the R&D Leadership Team, guiding regulatory readiness and quality governance for late-stage development, regulatory submissions, and commercial readiness. The position requires a senior leader with 16+ years in biologics quality, strong cross-functional

Qualifications

• Bachelor’s degree in a relevant scientific, engineering, quality, or related field; advanced degree preferred.
• Proven people-leadership experience and success driving organizational change.
• Demonstrated success developing or transforming a QMS for late-stage development and licensure.
• Direct experience supporting late-stage clinical development, process validation, PPQ, PAI readiness, and BLA/MAA submissions.
• Experience leading health authority inspections and interacting with FDA and other global regulatory agencies.

Responsabilités

• Develop and evolve a phase-appropriate QMS spanning GMP, GCP, GVP, and GLP.
• Serve as strategic advisor to executive leadership on quality and risk management.
• Embed quality culture across functions and development programs.
• Own quality governance, metrics, escalation pathways, and risk management frameworks.
• Provide oversight for GMP quality activities, QMS audits, vendor oversight, and CAPA program.
• Lead inspection readiness for FDA BIMO, PAIs, and other inspections.
• Identify and mitigate quality risks across outsourced development networks.

Connaissances

Leadership

Regulatory knowledge

Quality management

GxP compliance

Cross-functional collaboration

Formation

Bachelor's degree in a relevant field

Advanced degree preferred

Description du poste

Sabin Vaccine Institute, Inc. is seeking a Vice President of Quality to provide strategic leadership for GxP quality across GMP, GCP, GVP, and GLP within a virtual nonprofit organization.

The role reports to the President of R&D and sits on the R&D Leadership Team, guiding regulatory readiness and quality governance for late-stage development, regulatory submissions, and commercial readiness. The position requires a senior leader with 16+ years in biologics quality, strong cross-functional