Associate Director / Director, Quality Assurance

The role

This senior individual contributor will own document control, GMP training, and the vendor and supplier qualification and audit program. You will build and scale the Quality Management System for an outsourced manufacturing model and lead cross-functional quality initiatives.

What you will do

• Partner with the Head of QA to set quality strategy, priorities, and annual objectives
• Lead cross-functional quality initiatives with Manufacturing/CMC, Regulatory, Supply Chain, Clinical, and Commercial teams
• Own QA metrics and KPIs
• Lead inspection readiness and act as a front-room host or SME during FDA and other regulatory inspections
• Coach and mentor QA and cross-functional colleagues on GMP expectations
• Own the document control system including SOPs, work instructions, forms, specifications, and controlled records
• Manage the document lifecycle
• Own the GMP training program
• Own the supplier qualification program
• Plan and run the annual audit schedule for CMOs, testing labs, API and excipient suppliers, component and device suppliers, and GxP service providers

Required qualifications

• Bachelor's degree in a scientific or engineering discipline
• Minimum of 10+ years of QA experience
• Progressive QA experience in pharmaceutical, biotech, or combination products, including commercial-stage products
• Hands-on ownership of document control and GMP training systems
• Lead auditor experience with CMOs and suppliers
• Strong knowledge of 21 CFR 210/211, Part 11, ICH Q7–Q10, and EU GMP
• Proven ability to lead cross-functional work and influence without direct authority
• Direct participation in FDA or EU regulatory inspections

Nice to have

• Advanced degree
• Drug-device combination product experience (21 CFR Part 4, 820 / QMSR, ISO 13485)
• Veeva Vault QMS/QualityDocs administration or implementation
• ASQ CQA or other lead auditor certification
• Experience building quality systems at a small, virtual, or growing company

Benefits

• Equity
• 401k matching
• 100% employer paid Medical, Dental & Vision

About the company

ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with neffy®.