---
title: 'Associate Director / Director, Quality Assurance at ARS Pharmaceuticals Operations, Inc.'
canonical: 'https://feeny.ai/job/associate-director-director-quality-assurance-ars-pharmaceuticals-operations-50qe8f77mxng'
type: 'job'
last_seen: '2026-11-02'
---

# Associate Director / Director, Quality Assurance at ARS Pharmaceuticals Operations, Inc.

- **Company:** ARS Pharmaceuticals Operations, Inc.
- **Location:** San Diego, CA
- **Posted:** 2026-10-23
- **Last confirmed live:** 2026-11-02
- **Apply:** https://job-boards.greenhouse.io/arspharmaceuticalsoperationsinc/jobs/5461691008

## Job description

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 role is a senior individual contributor role that will work an onsite hybrid schedule at our San Diego corporate office in the Carmel Valley are.  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).
- 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.

At ARS, we are proud to offer a highly competitive compensation & benefits package.

The full-time salary range for this posted position is $206,000 to $230,000 and may be eligible for a discretionary annual performance bonus. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and other job-related factors permitted by law.

This position is also eligible for Equity, 401k matching, and our excellent benefits package including 100% employer paid Medical, Dental & Vision for employees. View the full package here: [ARS Careers Page](https://www.ars-pharma.com/careers)

ARS Pharmaceuticals believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. ARS Pharmaceuticals is also committed to providing reasonable accommodation to qualified individuals so that an individual can perform their job-related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at careers@ars-pharma.com

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

## About ARS Pharmaceuticals Operations, Inc.

## Company Overview
- **One-liner**: ARS Pharmaceuticals develops needle-free, patient-friendly emergency treatments for severe allergic reactions (anaphylaxis), with its FDA-approved neffy® (epinephrine nasal spray).
- **Entity Type**: Public (NASDAQ: SPRY, IPO November 2022)
- **Headquarters**: San Diego, California, United States
- **Founded**: 2015
- **Founders**: Richard Lowenthal, M.S., MSEL (President & CEO) and Sarina Tanimoto, M.D., M.B.A. (Chief Medical Officer)

## Core Business
- Primary industry/industries: Pharmaceutical manufacturing, biotechnology, allergy therapeutics.
- Target customers: Patients and caregivers at risk of type 1 allergic reactions (food, medications, insect bites) and the healthcare professionals who prescribe epinephrine.
- Mission or purpose statement: To develop safe and effective treatments that are needle-free, easy to carry, simple to administer, and help eliminate the anxiety and hesitation associated with using an injectable device. [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)

## Products & Services
- **neffy® (epinephrine nasal spray)**: The first and only FDA-approved needle-free epinephrine product for the emergency treatment of allergic reactions (anaphylaxis). It is also approved in Canada. ARS Pharma positions it as a convenient, portable alternative to auto-injectors like EpiPen. [ars-pharma.com](https://ars-pharma.com/)

## Market Standing
- **Valuation/Market Cap**: ~$803.5M (as of 2026). [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)
- **Key Metric**: Annual Revenue of **$84.3M** (latest reported). [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)
- **Notable Investors/Partners**: Lead investors include Deerfield (Series C, 2018), SR One (Series D, 2021). Post-IPO debt financing (2025) and a $100M debt round (2025). [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)
- **Growth Signals**: Employee headcount grew **23.2% YoY** to 142 people. The company’s share of the epinephrine market is expanding, backed by a dedicated commercial launch of neffy. Post-IPO, the company acquired Silverback Therapeutics (2022). [linkedin.com](https://www.linkedin.com/company/arspharmaceuticals)

## Competitive Advantages
- **First‑mover in needle‑free epinephrine**: neffy is the only FDA‑approved intranasal epinephrine, offering a clear compliance and usability advantage over injectables (needle‑free, no fear of needles, easier to carry).
- **Strong IP and formulation expertise**: Proprietary intranasal delivery system backed by clinical data and regulatory approvals.
- **Patient/caregiver centricity**: The product directly addresses hesitation and anxiety around injections, which historically leads to under‑treatment or delayed treatment during anaphylaxis.

## Strategic Focus
- **Commercial execution**: Scaling the launch of neffy in the U.S. and expanding into Canadian and international markets.
- **Market education**: Converting physicians and patients from injectable epinephrine to the needle‑free alternative.
- **Expanding indications**: Potential label expansions or new formulations for broader allergic reaction settings.

## Why Work Here
- **Culture**: Collaborative, entrepreneurial, and patient‑driven. The company describes itself as inclusive and innovative, focused on improving patient lives. [ars-pharma.com/careers](https://ars-pharma.com/careers/)
- **Work model**: Most positions are eligible for remote or flexible hybrid schedules.
- **Benefits**: ARS pays 100% of medical, dental, and vision premiums for employees and 80% for dependents. Includes a 401(k) with 5% match, Employee Stock Purchase Plan (15% discount), 15 days Flexible Time Off, 8 days sick leave, 8 paid holidays plus 3 floating holidays, wellness program, and various voluntary coverages (pet insurance, legalShield, critical illness). [ars-pharma.com/careers](https://ars-pharma.com/careers/)
- **Growth**: Rapidly expanding commercial-stage biotech with a recent approval and active hiring across sales, medical science liaison, and corporate functions.

## Sources
1. [ars-pharma.com](https://ars-pharma.com/)
2. [ir.ars-pharma.com/investor-relations](https://ir.ars-pharma.com/investor-relations)
3. [ars-pharma.com/careers](https://ars-pharma.com/careers/)
4. [ars-pharma.com/leadership](https://ars-pharma.com/leadership/)
5. [linkedin.com/company/arspharmaceuticals](https://www.linkedin.com/company/arspharmaceuticals)

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