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Salary: USD 206,000 - 230,000 / annual
ARS Pharmaceuticals is seeking an Associate Director / Director of Quality Assurance to lead quality systems and regulatory readiness for neffy®, the first FDA-approved needle-free epinephrine product. This is a senior individual contributor role based in San Diego (Carmel Valley) on a hybrid onsite schedule.
You will own the Quality Management System for an outsourced manufacturing model, serving as a senior quality voice with contract manufacturers, suppliers, and regulators. Key responsibilities include:
**Quality Leadership:** Partner with the Head of QA to set quality strategy and annual objectives. Lead cross-functional quality initiatives with Manufacturing, Regulatory, Supply Chain, Clinical, and Commercial teams. Own QA metrics and KPIs for quarterly Management Review. Lead inspection readiness and serve as SME during FDA and regulatory inspections. Coach and mentor QA colleagues on GMP expectations and deputize for the Head of QA as needed.
**Document Management:** Own the document control system (Veeva Vault QualityDocs), managing SOPs, work instructions, forms, specifications, and controlled records. Manage the full document lifecycle including authoring templates, review/approval routing, periodic review, effective dates, and archival. Ensure Part 11 and ALCOA+ compliance for electronic records and signatures. Maintain record retention schedules and inspection-ready retrieval.
**Training:** 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 completion and training effectiveness; escalate overdue training and close audit gaps.
**Vendor & Supplier Audits:** Own the supplier qualification program with risk-based classification, approved supplier lists, and requalification schedules. Plan and execute the annual audit schedule for CMOs, testing labs, API/excipient suppliers, component/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.
You will travel domestically and internationally up to 25% for audits, including time in GMP manufacturing areas with gowning.
**Requirements:**
*Required:*
- Bachelor's degree in a scientific or engineering discipline (advanced degree a plus); acceptable combination of education and relevant experience considered
- Minimum 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
