ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with neffy®, the first and only FDA-approved needle-free epinephrine product. If you’re motivated to make a meaningful impact, this is your opportunity to join a collaborative, entrepreneurial, and inclusive culture.

JOB SUMMARY

This is a senior individual contributor role that will work an onsite hybrid schedule at our San Diego corporate office in the Carmel Valley area. The Associate Director / Director, Quality Assurance owns the systems that keep us inspection-ready: 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, lead cross-functional quality initiatives, and act as a senior quality voice with contract manufacturers, suppliers, and regulators.

ESSENTIAL DUTIES & RESPONSIBILITIES

Quality leadership

Serve as a senior QA leader, partnering 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; prepare inputs for quarterly Management Review.
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; deputize for the Head of QA when needed.

Document management

Own the document control system (e.g., Veeva Vault QualityDocs): SOPs, work instructions, forms, specifications, and controlled records.
Manage the document lifecycle: authoring templates, review and approval routing, periodic review, effective dates, and archival.
Ensure Part 11 and data integrity (ALCOA+) compliance for electronic records and signatures.
Maintain record retention schedules and inspection-ready retrieval.

Training

Own the GMP training program: role-based curricula, training matrices, and new-hire onboarding.
Deliver or oversee annual cGMP, data integrity, and SOP training.
Track completion and training effectiveness; escalate overdue training and close gaps found in audits.

Vendor and supplier audits

Own the supplier qualification program: risk-based classification, approved supplier list, and requalification schedule.
Plan and run 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

KNOWLEDGE, SKILLS, AND ABILITIES

Influence: gets alignment from peers, partners, and executives without line authority.
Systems thinking: designs quality processes that scale and stay inspection-ready.
Audit judgment: finds real risk quickly and grades findings in proportion to it.
Communication: writes clear audit reports and presents confidently to regulators and leadership.
Office-based in San Diego (preferred), with domestic and international travel up to 25% for audits, including time in GMP manufacturing areas with gowning.

EDUCATION AND EXPERIENCE

Required

Bachelor's degree in a scientific or engineering discipline; advanced degree a plus. An acceptable combination of education and relevant experience will also be considered
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.

Preferred

Drug-device combination product experience (21 CFR Part 4, 820 / QMSR, ISO 13485).