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Salary: USD 145,000 - 185,000 / annual
ARS Pharmaceuticals is seeking a Manager of Quality Assurance to own batch disposition and product complaint management for neffy®, the first FDA-approved needle-free epinephrine product. This is a hands-on hybrid role based in the Carmel Valley area of San Diego, working daily with contract manufacturing organizations (CMOs), Regulatory, Supply Chain, and Medical Affairs teams.
Key responsibilities include:
**Batch Record Review & Disposition:** Review executed batch records, packaging records, and certificates of analysis from CMOs for accuracy, completeness, and cGMP compliance. Verify that deviations, out-of-specification (OOS) and out-of-trend (OOT) results, and change controls are closed or properly assessed before lot release. Prepare lot disposition packages and recommend release, rejection, or quarantine as QA approver. 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 end-to-end product complaint process including intake, triage, CMO investigation requests, trending, and closure within defined timelines. Assess complaints for reportability (Field Alert Reports, MDRs for combination products) in coordination with Regulatory and Pharmacovigilance. Lead or support root cause investigations and confirm corrective and preventive actions (CAPAs) are effective. Prepare complaint trend reports for management review and Annual Product Reviews.
**CMO Quality Oversight:** Serve as the day-to-day QA contact for assigned CMOs and testing labs. Review and approve CMO deviations, investigations, change controls, and CAPAs affecting products. Manage quality agreements and quality metrics; participate in business reviews and person-in-plant visits as needed. Support CMO audits and regulatory inspections.
**GMP Compliance & 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.
The role requires strong quality judgment, partner management skills, clear communication, and ownership mentality. Work is primarily office-based with occasional travel to CMO sites (including time in GMP manufacturing areas with gowning) and occasional after-hours support for urgent complaints or release needs.
**Requirements:**
Required:
- Bachelor's degree in chemistry, biology, pharmacy, engineering, or related science (or acceptable combination of education and relevant experience)
- Minimum 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)
