Chief Quality & Regulatory Officer

Nova Pneuma, Inc. a wholly owned subsidiary of Lee's Pharmaceuticals Holdings; Fremont (CA); On-site; USD 297,000 - 363,000; Full time

Job summary

Nova Pneuma, Inc. in Fremont, CA is seeking a strategic VP, Quality & Regulatory Affairs to define and drive global quality and regulatory programs across QA, QC, validation, and supplier quality.

This executive role partners with cross-functional leaders to ensure cGMP, GLP, GCP compliance and successful regulatory submissions. The successful candidate will lead a robust QMS, oversee inspections, and mentor teams while aligning quality objectives with the company's growth strategy in a

Qualifications

• 15+ years of progressive regulatory and QA/QC experience in pharma/biotech.
• 8+ years in an executive role with leadership over QA/QC and regulatory
• Experience leading multiple FDA and international regulatory inspections
• Thorough knowledge of cGMP, QSR, GLP, GCP and ICH requirements
• Experience with drug/device combination products and regulatory submissions

Responsibilities

• Provide strategic leadership and advise executive management and the Board on quality, compliance, regulatory, and quality culture.
• Maintain and improve a robust Quality Management System (QMS).
• Serve as executive leader for company-wide quality culture and continuous improvement.
• Support corporate growth, tech transfers, new product introductions, and commercialization.
• Oversee QA activities including Quality Systems, Document Control, Training, Change Control, Deviations, CAPA, Audits, Risk Management, and Product Release.
• Ensure compliance with FDA, EMA, and global authorities.
• Lead preparation of Quality content for regulatory submissions.
• Oversee QC activities including analytical testing and stability programs; ensure GMP and data integrity.
• Ensure readiness for regulatory inspections and serve as executive quality representative during inspections.
• Establish quality system metrics and KPIs to drive compliance and improvements.
• Determine Quality organization structure, staffing, and resource needs.
• Provide mentorship on diverse regulatory requirements and practices.

Skills

QMS Leadership

Regulatory Strategy

Regulatory Inspections

Cross-functional Leadership

GMP/Quality Standards

Stakeholder Management

Strategic Thinking

Problem Solving

Education

Bachelor's in Science

Advanced Degree Preferred

Job description

Nova Pneuma, Inc. in Fremont, CA is seeking a strategic VP, Quality & Regulatory Affairs to define and drive global quality and regulatory programs across QA, QC, validation, and supplier quality.

This executive role partners with cross-functional leaders to ensure cGMP, GLP, GCP compliance and successful regulatory submissions. The successful candidate will lead a robust QMS, oversee inspections, and mentor teams while aligning quality objectives with the company's growth strategy in a