---
title: 'Manager / Senior Manager, Quality Assurance at ARS Pharmaceuticals Operations, Inc.'
canonical: 'https://feeny.ai/job/manager-senior-manager-quality-assurance-ars-pharmaceuticals-operations-inc-san-mxs72zf7tbgp'
type: 'job'
last_seen: '2026-11-02'
---

# Manager / Senior Manager, Quality Assurance at ARS Pharmaceuticals Operations, Inc.

- **Company:** ARS Pharmaceuticals Operations, Inc.
- **Location:** San Diego, CA
- **Posted:** 2026-10-22
- **Last confirmed live:** 2026-11-02
- **Apply:** https://job-boards.greenhouse.io/arspharmaceuticalsoperationsinc/jobs/5461614008

## 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.

This is a hands-on role that will work an onsite hybrid schedule at our San Diego corporate office in the Carmel Valley area. The Manager / Senior Manager Quality Assurance owns batch disposition and product complaint management for products made at our contract manufacturing organizations (CMOs). You will review executed batch records, drive deviations and investigations to closure, and run the complaint process end to end so that every lot released meets cGMP and regulatory requirements. This is a hands-on role working daily with CMO quality teams, Regulatory, Supply Chain, and Medical Affairs.

## ESSENTIAL DUTIES & RESPONSIBILITIES:

Batch record review and disposition

- Review executed batch records, packaging records, and certificates of analysis from CMOs for accuracy, completeness, and cGMP compliance.
- Verify that deviations, OOS/OOT results, and change controls tied to each lot are closed or properly assessed before release.
- Prepare lot disposition packages and recommend release, rejection, or quarantine; act as QA approver per delegation.
- Review master batch records and specifications for new and revised products.
- Track batch release timelines and partner with Supply Chain to meet commercial and clinical supply needs.

Product complaint management

- Own the product complaint process: intake, triage, CMO investigation requests, trending, and closure within defined timelines.
- Assess complaints for reportability (e.g., Field Alert Reports, MDRs for combination products) with Regulatory and Pharmacovigilance.
- Lead or support root cause investigations and confirm CAPAs are effective.
- Prepare complaint trend reports for management review and Annual Product Reviews.

CMO Quality Oversight

- Serve as day-to-day QA contact for assigned CMOs and testing labs.
- Review and approve CMO deviations, investigations, change controls, and CAPAs affecting our products.
- Manage quality agreements and quality metrics; join business reviews and person-in-plant visits as needed.
- Support CMO audits and regulatory inspections.

GMP compliance and quality systems

- Maintain compliance with 21 CFR Parts 210/211, 21 CFR Part 4 (combination products), ICH Q7–Q10, and EU GMP as applicable.
- Author and revise SOPs for batch disposition and complaint handling.
- Contribute to Annual Product Reviews, recall readiness, and inspection readiness.
- Lead process improvements, and represent QA on cross-functional project teams.

KNOWLEDGE, SKILLS, AND ABILITIES:

- Quality judgment: makes sound, documented release and reportability decisions under time pressure.
- Partner management: holds CMOs to standards while keeping relationships productive.
- Communication: writes clear investigation summaries and explains risk to non-QA colleagues.
- Ownership: tracks open items to closure without being chased.
- Primarily office-based work with occasional travel to CMO sites, including time in GMP manufacturing areas with gowning. Occasional after-hours support for urgent complaints or release needs.

## EDUCATION AND EXPERIENCE:

Required

- Preferred Bachelor's degree in chemistry, biology, pharmacy, engineering, or related science. An acceptable combination of education and relevant experience will also be considered
- Minimum of 6+ years of QA experience
- Hands-on batch record review and lot disposition for commercial pharmaceutical or combination products.
- Direct experience managing product complaints, deviations, and CAPAs.
- Working knowledge of cGMP (21 CFR 210/211), ICH guidelines, and FDA expectations.
- Experience overseeing CMOs or external testing labs in a virtual or outsourced model.
- Strong technical writing and attention to detail.

## Preferred

- Drug-device combination product experience (21 CFR Part 4, 820 / QMSR).
- Sterile, nasal, or inhalation dosage form experience.
- Electronic QMS experience (e.g., Veeva Vault QualityDocs/QMS, MasterControl).
- ASQ certification (CQA, CQE, or CPGP).

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

The full-time salary range for this posted position is $145,000 to $185,000 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)

## Other roles at ARS Pharmaceuticals Operations, Inc.

- [Manager / Senior Manager, Technical Operations](https://feeny.ai/job/manager-senior-manager-technical-operations-ars-pharmaceuticals-operations-inc-rhfyzs1x0p1t) — San Diego, CA
- [Director / Senior Director, Technical Operations](https://feeny.ai/job/director-senior-director-technical-operations-ars-pharmaceuticals-operations-sh8kat2pw8gk) — San Diego, CA
- [Senior Director / Executive Director, Forecasting & New Product Planning](https://feeny.ai/job/senior-director-executive-director-forecasting-new-product-planning-ars-j0jdpcw15w83) — United States
- [Senior Director, Trade Strategy, Distribution & Strategic Accounts](https://feeny.ai/job/senior-director-trade-strategy-distribution-strategic-accounts-ars-1mpsqxtr0b3v) — San Diego, CA
- [Executive Director, Sales - West](https://feeny.ai/job/executive-director-sales-west-ars-pharmaceuticals-operations-inc-united-states-9cyq2vmb635z) — United States
- [Associate Director / Director, Quality Assurance](https://feeny.ai/job/associate-director-director-quality-assurance-ars-pharmaceuticals-operations-50qe8f77mxng) — San Diego, CA
- [Specialty Sales Representative - Miami to Fort Myers](https://feeny.ai/job/specialty-sales-representative-miami-to-fort-myers-ars-pharmaceuticals-1v38td6ttd2g) — United States
- [Specialty Sales Representative - Tampa / St. Petersburg / Sarasota](https://feeny.ai/job/specialty-sales-representative-tampa-st-petersburg-sarasota-ars-pharmaceuticals-1q6h69f0rckx) — United States
- [Specialty Sales Representative - Fresno, CA](https://feeny.ai/job/specialty-sales-representative-fresno-ca-ars-pharmaceuticals-operations-inc-08b9npa247t1) — United States
- [Specialty Sales Representative - Richmond, VA](https://feeny.ai/job/specialty-sales-representative-richmond-va-ars-pharmaceuticals-operations-inc-xz3nn7ybfrsg) — United States