Manager / Senior Manager, Quality Assurance

ARS Pharmaceuticals•San Diego, CA

4d•Hybrid

About The Position

ARS Pharmaceuticals is seeking a Manager / Senior Manager, Quality Assurance, to own batch disposition and product complaint management for products made at contract manufacturing organizations (CMOs). This hands-on role works with CMO quality teams, Regulatory, Supply Chain, and Medical Affairs to help ensure every released lot meets cGMP and regulatory requirements. The position follows an onsite hybrid schedule at the company’s corporate office in the Carmel Valley area of San Diego. The role includes reviewing executed batch and packaging records and certificates of analysis, assessing deviations and other quality events before release, preparing lot disposition packages, and recommending release, rejection, or quarantine. The position also owns the product complaint process from intake and triage through investigation, trending, and closure, including reportability assessments with Regulatory and Pharmacovigilance. As the day-to-day QA contact for assigned CMOs and testing laboratories, the role reviews and approves relevant quality events, manages quality agreements and metrics, and supports audits and regulatory inspections. It also maintains GMP compliance, authors and revises SOPs, contributes to Annual Product Reviews and inspection readiness, and leads process improvements and cross-functional work. Work is primarily office-based, with occasional travel to CMO sites, time in GMP manufacturing areas requiring gowning, and occasional after-hours support for urgent complaints or release needs.

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 quality judgment for release and reportability decisions under time pressure.
Ability to manage CMO partnerships, uphold standards, and maintain productive relationships.
Ability to communicate investigation findings clearly and explain risk to non-QA colleagues.
Ability to track open items through closure.
Ability to travel occasionally to CMO sites and enter GMP manufacturing areas requiring gowning.
Availability for occasional after-hours support for urgent complaints or release needs.

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 deviations, OOS/OOT results, and change controls associated with each lot are closed or properly assessed before release.
Prepare lot disposition packages and recommend release, rejection, or quarantine; act as QA approver when delegated.
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.
Own product complaint intake, triage, 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 CAPAs are effective.
Prepare complaint trend reports for management review and Annual Product Reviews.
Serve as 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, ICH, 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.