Director, Quality Assurance & Inspection Readiness (Hybrid)

ARS Pharmaceuticals Operations, Inc.; San Diego (CA); Hybrid; USD 206,000 - 230,000; Full time

Benefits offered by this job

Equity

401k matching

100% employer paid Medical, Dental & V

Job summary

ARS Pharmaceuticals is seeking an Associate Director / Director, Quality Assurance to own and scale the Quality Management System for our on-site hybrid San Diego HQ. You will lead document control, GMP training, and supplier audits, partnering with CMOs and regulators to ensure inspection readiness and data integrity.

You will guide QA strategy, mentor teams, and drive performance across the organization, with 10+ years in pharma QA and hands-on experience in audits and 21 CFR requirements.

Qualifications

• Influence without direct authority in cross-functional teams.
• Systems thinking to design scalable, inspection-ready QA processes.
• Audits: assess risk, prioritize findings, drive CAPA.
• Strong written and verbal communication with regulators and leadership.
• On-site in San Diego with travel up to 25% for audits.

Responsibilities

• Provide QA leadership alongside Head of QA to set strategy, priorities, and objectives.
• Lead cross-functional quality initiatives with Manufacturing/CMC, Regulatory, Supply Chain, Clinical and Commercial teams.
• Own QA metrics and participate in Management Review processes.
• Lead inspection readiness and act as SME during FDA and other inspections.
• Coach and mentor QA and cross-functional partners on GMP expectations.

Skills

Influence

Systems thinking

Audit judgment

Communication

San Diego office

Education

Bachelor’s degree in science or engineering

10+ years QA experience

Lead auditor experience with CMOs/suppliers

Tools

Veeva Vault QMS/QualityDocs

Job description

ARS Pharmaceuticals is seeking an Associate Director / Director, Quality Assurance to own and scale the Quality Management System for our on-site hybrid San Diego HQ. You will lead document control, GMP training, and supplier audits, partnering with CMOs and regulators to ensure inspection readiness and data integrity.

You will guide QA strategy, mentor teams, and drive performance across the organization, with 10+ years in pharma QA and hands-on experience in audits and 21 CFR requirements.