VP, Quality & Regulatory Excellence

Nova Pneuma, Inc.; Fremont (CA); On-site; USD 297,000 - 363,000; Full time

Benefits offered by this job

Discretionary bonus

Health benefits

Job summary

Nova Pneuma, Inc. seeks an executive leader for Quality & Regulatory Affairs to shape the global quality strategy and regulatory pathway.

This role oversees QA, QC, validation, supplier quality, and quality systems across development and manufacturing, ensuring cGMP compliance and successful regulatory submissions. The VP partners with cross-functional teams to align quality objectives with business goals, lead regulatory inspections, and drive continuous improvement.

Qualifications

• Extensive knowledge of global GMP regulations (FDA/EMA/ICH) and international standards.
• Proven ability to lead QA/QC, regulatory affairs, and compliance programs at executive level.
• Demonstrated success managing regulatory inspections and complex quality systems.

Responsibilities

• Provide strategic leadership for Quality and Regulatory functions across development and manufacturing.
• Maintain and improve the Quality Management System (QMS) for product development and manufacturing.
• Lead regulatory submissions and inspections with global health authorities.
• Drive continuous improvement and quality culture across the organization.
• Oversee Quality Assurance, Quality Control, risk management and CAPA programs.

Skills

Global GMP knowledge

Regulatory inspections leadership

QA/QC leadership

Cross-functional collaboration

Strategic leadership

Education

Bachelor’s degree in a scientific field

Advanced degree preferred

Job description

Nova Pneuma, Inc. seeks an executive leader for Quality & Regulatory Affairs to shape the global quality strategy and regulatory pathway.

This role oversees QA, QC, validation, supplier quality, and quality systems across development and manufacturing, ensuring cGMP compliance and successful regulatory submissions. The VP partners with cross-functional teams to align quality objectives with business goals, lead regulatory inspections, and drive continuous improvement.