Associate Director, electronic Quality Management System (eQMS) (Biotech)

Location: Brisbane, California, United States — 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 processes, SOPs, and workflows for deviations, investigations, CAPAs, change controls, complaints, quality metrics, and other core quality systems.
• Lead the implementation, configuration, validation support, and optimization of the electronic Quality Management System.
• Manage and review regulated quality records while ensuring data integrity, traceability, and ALCOA+ compliance.
• Partner with Technical Operations, Clinical, Regulatory Affairs, and other stakeholders on system governance, roles, reporting, and requirements.
• Analyze quality metrics and trends, identify systemic risks, and drive continuous improvement.
• Develop QMS training, support inspection readiness, and maintain compliance with cGMPs and regulatory requirements.

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.
• Experience implementing, administering, configuring, validating, and improving an eQMS and other validated computerized systems.
• Hands-on experience with deviations, investigations, CAPAs, change controls, quality data management, reporting, and data integrity.
• Strong Microsoft Office skills, organization, attention to detail, independent judgment, and cross-functional collaboration.
• Excellent written and verbal communication skills with the ability to influence stakeholders at all organizational levels.

Culture & Benefits

• Collaborative, team-oriented environment.
• Solutions- and results-oriented approach.
• Hands-on, resourceful culture open to diverse perspectives.
• Onsite work in Brisbane, California.