Associate Director / Director, Quality Assurance

<div class="content-intro"><p></p> <div> <p class="x_MsoNormal"><span data-olk-copy-source="MessageBody">ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with <strong>neffy®</strong>, 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.</span></p> </div> <div></div></div><p><strong>JOB SUMMARY:</strong></p> <p>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.</p> <p><strong>ESSENTIAL DUTIES & RESPONSIBILITIES:</strong></p> <p><strong>Quality leadership</strong></p> <ul> <li>Serve as a senior QA leader, partnering with the Head of QA to set quality strategy, priorities, and annual objectives.</li> <li>Lead cross-functional quality initiatives with Manufacturing/CMC, Regulatory, Supply Chain, Clinical, and Commercial teams.</li> <li>Own QA metrics and KPIs; prepare inputs for quarterly Management Review.</li> <li>Lead inspection readiness and act as a front-room host or SME during FDA and other regulatory inspections.</li> <li>Coach and mentor QA and cross-functional colleagues on GMP expectations; deputize for the Head of QA when needed.</li> </ul> <p><strong>Document management</strong></p> <ul> <li>Own the document control system (e.g., Veeva Vault QualityDocs): SOPs, work instructions, forms, specifications, and controlled records.</li> <li>Manage the document lifecycle: authoring templates, review and approval routing, periodic review, effective dates, and archival.</li> <li>Ensure Part 11 and data integrity (ALCOA+) compliance for electronic records and signatures.</li> <li>Maintain record retention schedules and inspection-ready retrieval.</li> </ul> <p><strong>Training</strong></p> <ul> <li>Own the GMP training program: role-based curricula, training matrices, and new-hire onboarding.</li> <li>Deliver or oversee annual cGMP, data integrity, and SOP training.</li> <li>Track completion and training effectiveness; escalate overdue training and close gaps found in audits.</li> </ul> <p><strong>Vendor and supplier audits</strong></p> <ul> <li>Own the supplier qualification program: risk-based classification, approved supplier list, and requalification schedule.</li> <li>Plan and run the annual audit schedule for CMOs, testing labs, API and excipient suppliers, component and device suppliers, and GxP service providers.</li> <li>Lead on-site and remote audits; write reports, approve audit responses, and verify CAPA effectiveness.</li> <li>Negotiate and maintain quality agreements; monitor supplier performance and escalate quality issues.</li> <li>Support internal audits of QMS processes</li> </ul> <p><strong>KNOWLEDGE, SKILLS, AND ABILITIES:</strong></p> <ul> <li><strong>Influence:</strong> gets alignment from peers, partners, and executives without line authority.</li> <li><strong>Systems thinking:</strong> designs quality processes that scale and stay inspection-ready.</li> <li><strong>Audit judgment:</strong> finds real risk quickly and grades findings in proportion to it.</li> <li><strong>Communication:</strong> writes clear audit reports and presents confidently to regulators and leadership.</li> <li><strong>Office-based in San Diego</strong> (preferred), with domestic and international travel up to 25% for audits, including time in GMP manufacturing areas with gowning.</li> </ul> <p><strong> </strong><strong>EDUCATION AND EXPERIENCE:</strong></p> <p><strong>Required</strong></p> <ul> <li>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</li> <li>Minimum of 10+ years of QA experience</li> <li>Progressive QA experience in pharmaceutical, biotech, or combination products, including commercial-stage products.</li> <li>Hands-on ownership of document control and GMP training systems.</li> <li>Lead auditor experience with CMOs and suppliers; strong knowledge of 21 CFR 210/211, Part 11, ICH Q7–Q10, and EU GMP.</li> <li>Proven ability to lead cross-functional work and influence without direct authority.</li> <li>Direct participation in FDA or EU regulatory inspections.</li> </ul> <p><strong>Preferred</strong></p> <ul> <li>Drug-device combination product experience (21 CFR Part 4, 820 / QMSR, ISO 13485).</li> <li>Veeva Vault QMS/QualityDocs administration or implementation.</li> <li>ASQ CQA or other lead auditor certification.</li> <li>Experience b