Vice President of Quality

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

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🌟 Head of Quality (Senior / Executive Director)

Are you ready to lead Quality through one of the most exciting phases in a company’s journey — from late-stage development to commercial launch?

We’re partnered with an innovative small molecule biopharmaceutical company advancing toward our first NDA submission and seeking a Head of Quality to shape, lead, and scale their quality operations. This is a rare opportunity to make a defining impact on a growing organization with a mission to deliver high-quality therapeutics to patients worldwide.

What You’ll Do

• Lead and inspire the Quality Assurance and Quality Control functions, fostering a culture of excellence, collaboration, and accountability.
• Build, refine, and execute a fit-for-purpose quality system that supports both regulatory compliance and business agility.
• Drive GxP compliance (GMP, GLP, GCP) and readiness for NDA submission and product launch.
• Serve as a key voice in cross-functional leadership, partnering with Manufacturing, Regulatory Affairs, and R&D.
• Oversee audits, inspections, deviations, CAPAs, and change controls with a pragmatic approach.

What You Bring

• 15+ years of experience in pharmaceutical Quality Assurance and/or Quality Control, including at least 5 years in a senior leadership role.
• Proven success in NDA preparation and commercial readiness within small molecule drug development.
• Strong grasp of FDA, EMA, and ICH regulations with the confidence to represent Quality in front of regulators and partners.
• Strategic yet hands‑on leadership style — equally comfortable defining vision and diving into details.
• Flexible, forward‑thinking approach to SOPs and quality frameworks — you know how to balance compliance with efficiency.

Apply directly or email

Seniority level

Executive

Employment type

Full‑time

Job function

Quality Assurance, Science, and Project Management

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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