Associate Director / Director, Quality Assurance

ARS Pharmaceuticals Operations, Inc.•San Diego, CA

8h•$206,000 - $230,000•Hybrid

About The Position

ARS Pharmaceuticals is seeking a senior individual contributor to own key quality systems that support inspection readiness, including document control, GMP training, and vendor and supplier qualification and audits. The role will build and scale the Quality Management System for an outsourced manufacturing model, lead cross-functional quality initiatives, and serve as a senior quality representative with contract manufacturers, suppliers, and regulators. The position follows an onsite hybrid schedule at the company’s San Diego corporate office in the Carmel Valley area, with domestic and international travel of up to 25% for audits, including time in GMP manufacturing areas requiring gowning. The Associate Director / Director partners with the Head of QA on quality strategy, priorities, and annual objectives; leads quality initiatives across relevant functions; owns quality metrics and contributes to quarterly Management Reviews; and leads inspection readiness, including serving as a front-room host or subject matter expert during FDA and other regulatory inspections. The role also coaches colleagues on GMP expectations and may deputize for the Head of QA. Responsibilities include administering the document control system and document lifecycle; ensuring Part 11 and ALCOA+ data integrity compliance; maintaining record retention and retrieval; managing the GMP training program and training effectiveness; and owning risk-based supplier qualification, audits, quality agreements, and supplier performance oversight. The role supports internal QMS audits and oversees audit responses and CAPA effectiveness.

Requirements

Bachelor's degree in a scientific or engineering discipline, or an acceptable combination of education and relevant experience.
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.
Ability to travel domestically and internationally up to 25% for audits, 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 act 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 and 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 inspection-ready 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 conduct the annual audit schedule for CMOs, testing labs, API and excipient suppliers, component and device suppliers, and GxP service providers.
Lead on-site 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.