Manager / Senior Manager, Quality Assurance

The role

This person will own batch disposition and product complaint management for products made at contract manufacturing organizations. They will review batch records, drive investigations to closure, and manage the complaint process to ensure compliance with cGMP and regulatory requirements.

What you will do

• Review executed batch records, packaging records, and certificates of analysis from CMOs
• Verify that deviations, OOS/OOT results, and change controls are closed or assessed before release
• Prepare lot disposition packages and recommend release, rejection, or quarantine
• Review master batch records and specifications for new and revised products
• Track batch release timelines and partner with Supply Chain
• Own the product complaint process including intake, triage, investigation requests, trending, and closure
• Assess complaints for reportability 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 labs

Required qualifications

• Minimum of 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

Nice to have

• Bachelor's degree in chemistry, biology, pharmacy, engineering, or related science
• 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)

Benefits

• Equity
• 401k matching
• 100% employer paid Medical, Dental & Vision

About the company

ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions with neffy®.