Chief Quality & Regulatory Strategy Officer

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

Benefits offered by this job

Discretionary bonus program

Health and other benefits

Job summary

Nova Pneuma, Inc. seeks an accomplished executive to lead Quality & Regulatory Affairs.

The VP will steer global quality strategy, oversee QMS, regulatory compliance, and readiness for FDA/EMA inspections, while partnering with manufacturing, development and supply chain to ensure cGMP adherence across all stages. The role demands extensive experience in pharmaceutical/biotech quality systems, regulatory submissions, and cross-functional leadership, with a track record of delivering compliant,

Qualifications

• Extensive knowledge of global GMP regulations and ICH standards.
• Proven ability to lead QMS in biotech/pharma settings.
• Experience managing regulatory inspections and compliance.
• Knowledge of GLP, GCP and regulatory requirements for drug-device products.
• Ability to advance products from development to launch with regulatory insights.

Responsibilities

• Provide strategic leadership for quality, regulatory and quality culture.
• Oversee QMS, document control, training, deviations, CAPA and audits.
• Lead readiness for regulatory inspections and liaison with authorities.
• Direct QA/QC activities across development, clinical and commercial operations.
• Staffing, resource planning and mentorship for regulatory teams.

Skills

GMP Regulations

Regulatory Compliance

Quality Management

Leadership & Strategy

Cross-functional Collaboration

Regulatory Inspections

Quality Systems

Risk Management

CQA/QA Experience

Education

Bachelor’s degree in scientific discipline

Advanced degree preferred

Job description

Nova Pneuma, Inc. seeks an accomplished executive to lead Quality & Regulatory Affairs.

The VP will steer global quality strategy, oversee QMS, regulatory compliance, and readiness for FDA/EMA inspections, while partnering with manufacturing, development and supply chain to ensure cGMP adherence across all stages. The role demands extensive experience in pharmaceutical/biotech quality systems, regulatory submissions, and cross-functional leadership, with a track record of delivering compliant,