Global Head of Quality & Regulatory Affairs

Nova Pneuma; Colorado; Presencial; USD 330.000 - 390.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Discretionary bonus

Health benefits

Competitive compensation package

Descripción de la vacante

Nova Pneuma, Inc. seeks a VP to define and execute the strategic direction for Quality and Regulatory Affairs across development, clinical and commercial manufacturing.

This executive leads QA, QC, compliance, validation, supplier quality and quality systems, shaping a culture of excellence. Partnering with CMC, Manufacturing, Clinical Development, Supply Chain and external partners, the role ensures compliance with FDA/EMA/ICH and global regulations, driving inspections readiness and continuous

Formación

• Bachelor’s degree in scientific discipline; advanced degree preferred.
• 15+ years in regulatory and QA/QC with 8+ years executive level.
• Experience leading FDA and international regulatory inspections.
• Knowledge of cGMP, QSR, GLP, GCP, ICH standards.

Responsabilidades

• Provide strategic leadership on quality and regulatory strategy.
• Maintain and improve the Quality Management System (QMS).
• Lead company-wide culture of quality, compliance, and improvement.
• Oversee regulatory submissions and inspections.

Conocimientos

GMP regulations

QA/QC leadership

Regulatory inspections

Cross-functional leadership

Quality systems

Risk management

Executive leadership

Educación

Bachelor's degree

Advanced degree preferred

Descripción del empleo

Nova Pneuma, Inc. seeks a VP to define and execute the strategic direction for Quality and Regulatory Affairs across development, clinical and commercial manufacturing.

This executive leads QA, QC, compliance, validation, supplier quality and quality systems, shaping a culture of excellence. Partnering with CMC, Manufacturing, Clinical Development, Supply Chain and external partners, the role ensures compliance with FDA/EMA/ICH and global regulations, driving inspections readiness and continuous