Manager / Senior Manager, Quality Assurance

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).
• Sterile, nasal, or inhalation dosage form experience.
• Electronic QMS experience (e.g., Veeva Vault QualityDocs/QMS, MasterControl).
• ASQ certification (CQA, CQE, or CPGP).