Associate Director / Director, Quality Assurance

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

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 [email protected]

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