QA Manager - Batch Release & Quality Compliance (Hybrid)

ARS Pharmaceuticals Operations, Inc.; San Diego (CA); Hybrid; USD 145,000 - 185,000; Full time

Benefits offered by this job

Equity

401k matching

Employer-paid Medical/Dental/Vision

Job summary

ARS Pharmaceuticals Operations, Inc. is seeking a Manager/Senior Manager, Quality Assurance to lead batch disposition and the end-to-end product complaint process at our San Diego campus.

This onsite hybrid role partners with CMOs, Regulatory, Supply Chain, and Medical Affairs to ensure cGMP compliance and timely product releases. You will drive deviations/investigations to closure, manage QA activities with CMOs, and maintain QMS processes (SOPs, CAPAs, recalls) in a fast-paced environment

Qualifications

• Bachelor’s degree in science or engineering; relevant experience considered
• Minimum 6+ years of QA experience in pharma or combination products
• Hands-on batch record review and lot disposition for commercial products
• Direct experience managing product complaints, deviations, and CAPAs
• Working knowledge of cGMP (21 CFR 210/211), ICH guidelines, FDA expectations
• Experience overseeing CMOs or external labs in outsourced models
• Strong technical writing and attention to detail

Responsibilities

• Review batch records, packaging records, and COAs for cGMP compliance
• Close deviations, OOS/OOT results, and change controls before release
• Prepare lot disposition packages and act as QA approver
• Review master batch records and specifications for products
• Coordinate batch release timelines with Supply Chain
• Own the product complaint process from intake to closure
• Lead RCIs and ensure CAPAs are effective
• Prepare complaint trend reports for mgmt review
• Oversee CMO QA activities and audits
• Maintain compliance with 21 CFR Parts 210/211, ICH, EU GMP
• Author and revise SOPs for batch disposition and complaints
• Support Annual Product Reviews and recall readiness
• Lead process improvements and cross-functional collaboration

Skills

Quality judgment

Partner management

Communication

Ownership

Education

Bachelor's degree in chemistry/biology/pharmacy/engineering

ASQ certification (CQA/CQE/CPGP)

Tools

Veeva Vault QMS

MasterControl

Job description

ARS Pharmaceuticals Operations, Inc. is seeking a Manager/Senior Manager, Quality Assurance to lead batch disposition and the end-to-end product complaint process at our San Diego campus.

This onsite hybrid role partners with CMOs, Regulatory, Supply Chain, and Medical Affairs to ensure cGMP compliance and timely product releases. You will drive deviations/investigations to closure, manage QA activities with CMOs, and maintain QMS processes (SOPs, CAPAs, recalls) in a fast-paced environment