Head of Quality — NDA-Ready Biotech Leader

Hartmann Young; San Diego (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

An innovative biopharmaceutical firm is seeking a Head of Quality to lead and scale their quality operations from late-stage development to commercial launch. This role requires over 15 years of experience in pharmaceutical Quality Assurance with proven success in NDA preparation. The ideal candidate will foster a culture of excellence and collaborate across functions, ensuring regulatory compliance and readiness for product launches.

Qualifications

• 15+ years of experience in pharmaceutical Quality Assurance and/or Quality Control.
• At least 5 years in a senior leadership role.
• Proven success in NDA preparation and commercial readiness.

Responsibilities

• Lead and inspire the Quality Assurance and Quality Control functions.
• Build and execute a fit-for-purpose quality system for compliance.
• Drive GxP compliance and readiness for NDA submission.

Skills

Pharmaceutical Quality Assurance

NDA preparation

Regulatory compliance

Leadership

FDA regulations

Small molecule drug development

Job description

An innovative biopharmaceutical firm is seeking a Head of Quality to lead and scale their quality operations from late-stage development to commercial launch. This role requires over 15 years of experience in pharmaceutical Quality Assurance with proven success in NDA preparation. The ideal candidate will foster a culture of excellence and collaborate across functions, ensuring regulatory compliance and readiness for product launches.