Associate Director / Director, Quality Assurance

ARS Pharmaceuticals • San Diego, CA

3d • Hybrid

About The Position

ARS Pharmaceuticals is seeking a senior individual contributor to own and scale key Quality Management System areas for an outsourced manufacturing model, including document control, GMP training, and vendor and supplier qualification and audits. The role partners with the Head of QA on quality strategy and objectives, leads cross-functional quality initiatives, owns QA metrics and Management Review inputs, and supports inspection readiness. It serves as a senior quality contact for contract manufacturers, suppliers, and regulators, and may deputize for the Head of QA when needed.

The position is based at the company’s San Diego corporate office and follows an onsite hybrid schedule. Domestic and international travel of up to 25% is expected for audits, including time in GMP manufacturing areas requiring gowning.

The full-time salary range is $206,000 to $230,000. The role may be eligible for a discretionary annual performance bonus and equity. ARS Pharmaceuticals also offers 401(k) matching and benefits including 100% employer-paid medical, dental, and vision coverage for employees.

Requirements

• Bachelor’s degree in a scientific or engineering discipline, or an acceptable combination of education and relevant experience.
• At least 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.
• Ability to travel domestically and internationally up to 25%, including time in GMP manufacturing areas with gowning.

Nice To Haves

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

Responsibilities

• 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 and prepare inputs for quarterly Management Review.
• Lead inspection readiness and serve as a front-room host or subject matter expert during FDA and other regulatory inspections.
• Coach and mentor QA and cross-functional colleagues on GMP expectations; deputize for the Head of QA when needed.
• Own the document control system for SOPs, work instructions, forms, specifications, and controlled records.
• Manage document authoring templates, review and approval routing, periodic review, effective dates, and archival.
• Ensure Part 11 and ALCOA+ data integrity compliance for electronic records and signatures.
• Maintain record retention schedules and ensure inspection-ready record retrieval.
• Own the GMP training program, including role-based curricula, training matrices, and new-hire onboarding.
• Deliver or oversee annual cGMP, data integrity, and SOP training.
• Track training completion and effectiveness, escalate overdue training, and close gaps identified in audits.
• Own the supplier qualification program, including risk-based classification, the approved supplier list, and requalification schedules.
• Plan and run the annual audit schedule for CMOs, testing labs, API and excipient suppliers, component and device suppliers, and GxP service providers.
• Lead onsite and remote audits; write reports, approve audit responses, and verify CAPA effectiveness.
• Negotiate and maintain quality agreements, monitor supplier performance, and escalate quality issues.
• Support internal audits of QMS processes.

Benefits

• 401(k) matching.
• Equity eligibility.
• 100% employer-paid medical, dental, and vision coverage for employees.
• May be eligible for a discretionary annual performance bonus.
• Excellent benefits package; further details are available on the ARS Careers Page.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior