Manager, Quality Control – Stability and Sample Management (Pharmaceuticals)

TL;DR

Manager, Quality Control – Stability and Sample Management (Pharmaceuticals): Overseeing daily QC stability and sample management operations to support GMP operations at hirify.global Gene Therapy with an accent on study initiation, sample pulls, and regulatory compliance. Focus on managing stability programs, authoring GxP protocols, and ensuring accurate data trending using JMP and Labware LIMS.

Location: Full-time, in-person presence required in San Diego office

Salary: $124,000 – $161,000 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Lead QC Stability and Sample Management operations, managing staff activities, schedules, and training.
• Oversee GMP stability programs, including study initiation and sample pulls for cell banks, drug substances, and drug products.
• Author GxP stability protocols, interim reports, and final reports for stability studies.
• Analyze and trend stability data using JMP and Labware LIMS, managing deviations, CAPAs, and change controls.
• Collaborate with QA, Manufacturing, and CMOs to ensure timelines and testing turnaround times are met.
• Manage lab facilities, including equipment maintenance, stability chambers, and sample chain of custody.

Requirements

• Bachelor’s degree with 8+ years of experience or Master’s degree with 5+ years of relevant pharmaceutical experience.
• Proven experience managing GMP stability studies across various drug development phases.
• Deep knowledge of ICH, CFR, and FDA regulatory requirements for stability testing.
• Strong technical writing and analytical skills for data collection and conclusion drawing.
• Proficiency in MS Office and specialized tools like Oracle, Veeva, JMP, and LIMS.
• Must be based in or able to work full-time from San Diego.

Nice to have

• Commercial GMP experience in stability and sample management.
• Experience with Smartsheet, JMP statistical software, and Labware LIMS.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with competitive company match and annual equity awards.
• Generous paid time off, fertility and family-forming benefits, and caregiver support.
• Access to Company Learning Institute featuring LinkedIn Learning and leadership programs.
• Employee resource groups and meaningful volunteer opportunities.