Associate Director, Electronic Quality Management System (eQMS)

Location: Brisbane, California — onsite

Salary: $200,700–$233,500 per year

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases through an AI-integrated discovery engine.

What you will do

• Manage and maintain QMS processes, SOPs, and workflows for deviations, investigations, CAPAs, change controls, complaints, and quality metrics.
• Lead or support the implementation, configuration, validation, optimization, and lifecycle management of the electronic Quality Management System.
• Execute, review, and manage regulated quality records while ensuring data integrity, traceability, and ALCOA+ compliance.
• Partner with Technical Operations, Clinical, Regulatory Affairs, and other stakeholders on data governance, system roles, configuration, and reporting.
• Develop and present quality metrics and KPIs, perform trend analysis, identify systemic risks, and drive continuous improvement.
• Deliver QMS training, support inspection readiness, and promote cross-functional quality ownership.

Requirements

• Bachelor’s degree in Computer Science, Life Sciences, or a related field, or equivalent relevant experience.
• At least 8 years of experience in the pharmaceutical or biotechnology industry, including 6 or more years in Quality Systems or Quality Assurance.
• Demonstrated experience implementing, administering, configuring, validating, and improving an eQMS.
• Hands-on experience managing deviations, investigations, CAPAs, and change controls in a regulated environment.
• Strong knowledge of quality-system data management, reporting, data integrity principles, validated computerized systems, and cGMP requirements.
• Strong communication, organization, analytical, prioritization, and cross-functional collaboration skills.

Culture & Benefits

• Highly collaborative, team-oriented working environment.
• Solutions- and results-oriented approach.
• Hands-on, resourceful culture open to diverse points of view.