Manager / Senior Manager, Quality Assurance
About The Position
ARS Pharmaceuticals is seeking a Manager / Senior Manager, Quality Assurance to own batch disposition and product complaint management for products manufactured by contract manufacturing organizations (CMOs). This hands-on role reviews executed batch records, drives deviations and investigations to closure, and manages the complaint process end to end to help ensure every released lot meets cGMP and regulatory requirements. The role works daily with CMO quality teams, Regulatory, Supply Chain, and Medical Affairs, on an onsite hybrid schedule at the company’s San Diego corporate office in the Carmel Valley area. The position oversees batch record review and lot disposition, complaint handling, CMO quality oversight, and GMP compliance and quality systems. It supports commercial and clinical supply needs, contributes to Annual Product Reviews and inspection readiness, and leads process improvements and cross-functional quality work. Work is primarily office-based, with occasional travel to CMO sites and time in GMP manufacturing areas requiring gowning. Occasional after-hours support may be needed for urgent complaints or release needs. The posted full-time salary range is $145,000 to $185,000. The role may be eligible for a discretionary annual performance bonus and equity. ARS Pharmaceuticals also offers 401(k) matching and a benefits package that includes 100% employer-paid medical, dental, and vision coverage for employees. Actual pay is determined by considering qualifications, relevant experience, education and credentials, subject matter expertise, and other job-related factors permitted by law.
Requirements
- Bachelor’s degree in chemistry, biology, pharmacy, engineering, or a related science; an acceptable combination of education and relevant experience will also be considered.
- At least 6 years of QA experience.
- Hands-on batch record review and lot disposition experience 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 laboratories in a virtual or outsourced model.
- Strong technical writing skills and attention to detail.
- Sound, documented release and reportability judgment under time pressure.
- Ability to hold CMOs to standards while maintaining productive relationships.
- Ability to communicate investigation findings clearly and explain risk to non-QA colleagues.
- Ability to track open items through closure independently.
Nice To Haves
- Drug-device combination product experience, including 21 CFR Part 4 and 820/QMSR.
- Sterile, nasal, or inhalation dosage-form experience.
- Electronic QMS experience, such as Veeva Vault QualityDocs/QMS or MasterControl.
- ASQ certification, such as CQA, CQE, or CPGP.
Responsibilities
- 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 associated with each lot are closed or appropriately assessed before release.
- Prepare lot disposition packages and recommend release, rejection, or quarantine; act as QA approver as delegated.
- Review master batch records and specifications for new and revised products.
- Track batch release timelines and work with Supply Chain to meet commercial and clinical supply needs.
- Manage product complaints from intake and triage through CMO investigation requests, trending, and timely closure.
- Assess complaint reportability, including Field Alert Reports and MDRs for combination products, with Regulatory and Pharmacovigilance.
- Lead or support root-cause investigations and confirm CAPA effectiveness.
- Prepare complaint trend reports for management review and Annual Product Reviews.
- Serve as the day-to-day QA contact for assigned CMOs and testing laboratories.
- Review and approve CMO deviations, investigations, change controls, and CAPAs affecting company products.
- Manage quality agreements and quality metrics; participate in business reviews and person-in-plant visits as needed.
- Support CMO audits and regulatory inspections.
- Maintain compliance with applicable 21 CFR Parts 210/211, 21 CFR Part 4, ICH Q7–Q10, and EU GMP requirements.
- 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.
Benefits
- 401(k) matching.
- Equity eligibility.
- 100% employer-paid medical, dental, and vision coverage for employees.
- Competitive compensation and benefits package.
- Potential eligibility for a discretionary annual performance bonus.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
