What are the responsibilities and job description for the Vice President of Quality position at Hartmann Young?
🌟 Head of Quality (Senior / Executive Director)
Location: San Diego, CA (Hybrid) or Remote – USA
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
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.
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