Manager / Senior Manager, Quality Assurance

ARS Pharmaceuticals Operations, Inc.; San Diego (CA); Híbrido; USD 145 000 - 185 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Equity

401k matching

Employer-paid Medical/Dental/Vision

Resumo da oferta

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

Qualificações

• 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

Responsabilidades

• 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

Conhecimentos

Quality judgment

Partner management

Communication

Ownership

Formação académica

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

ASQ certification (CQA/CQE/CPGP)

Ferramentas

Veeva Vault QMS

MasterControl

Descrição da oferta de emprego

Manager / Senior Manager, Quality Assurance

ARS Pharmaceuticals is a fast-growing, innovative company dedicated to transforming the treatment of severe allergic reactions withneffy®,thefirst and only FDA-approved needle-free epinephrine product. If you’re motivated to make a meaningful impact, this is your opportunity to join a collaborative, entrepreneurial, and inclusive culture.

This is a hands-on role that will work an onsite hybrid schedule at our San Diego corporate office in the Carmel Valley area. The Manager / Senior Manager Quality Assurance owns batch disposition and product complaint management for products made at our contract manufacturing organizations (CMOs). You will review executed batch records, drive deviations and investigations to closure, and run the complaint process end to end so that every lot released meets cGMP and regulatory requirements. This is a hands-on role working daily with CMO quality teams, Regulatory, Supply Chain, and Medical Affairs.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Batch record review and disposition

• 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 tied to each lot are closed or properly assessed before release.
• Prepare lot disposition packages and recommend release, rejection, or quarantine; act as QA approver per delegation.
• 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 product complaint process: intake, triage, CMO investigation requests, trending, and closure within defined timelines.
• Assess complaints for reportability (e.g., Field Alert Reports, 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.

CMO Quality Oversight

• Serve as day-to-day QA contact for assigned CMOs and testing labs.
• Review and approve CMO deviations, investigations, change controls, and CAPAs affecting our products.
• Manage quality agreements and quality metrics; join business reviews and person-in-plant visits as needed.
• Support CMO audits and regulatory inspections.

GMP compliance and 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.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Quality judgment: makes sound, documented release and reportability decisions under time pressure.
• Partner management: holds CMOs to standards while keeping relationships productive.
• Communication: writes clear investigation summaries and explains risk to non-QA colleagues.
• Ownership: tracks open items to closure without being chased.
• Primarily office-based work with occasional travel to CMO sites, including time in GMP manufacturing areas with gowning. Occasional after-hours support for urgent complaints or release needs.

EDUCATION AND EXPERIENCE:

Required

• Preferred Bachelor's degree in chemistry, biology, pharmacy, engineering, or related science. An acceptable combination of education and relevant experience will also be considered
• 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.

Preferred

• Drug-device combination product experience (21 CFR Part 4, 820 / QMSR).
• Electronic QMS experience (e.g., Veeva Vault QualityDocs/QMS, MasterControl).
• ASQ certification (CQA, CQE, or CPGP).

At ARS, we are proud to offer a highly competitive compensation & benefits package.

The full-time salary range for this posted position is $145,000 to $185,000 and may be eligible for a discretionary annual performance bonus. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and other job-related factors permitted by law.

This position is also eligible for Equity, 401k matching, and our excellent benefits package including 100% employer paid Medical, Dental & Vision for employees. View the full package here: ARS Careers Page

ARS Pharmaceuticals believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. ARS Pharmaceuticals is also committed to providing reasonable accommodation to qualified individuals so that an individual can perform their job-related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [e-mail]

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.