More jobs:
Vice President of Quality
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-01-01
Listing for:
Hartmann Young
Full Time
position Listed on 2026-01-01
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
Direct message the job poster from Hartmann Young
Biotech’s Leading Talent Partner | 90,000+ Connections
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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