Director of Quality Assurance (AI/ML)

Location: South San Francisco, CA; in-person hybrid schedule of either three days per week or one full week per month

Salary: $205,000–$218,000 annually for successful US-based applicants, plus eligibility for an annual performance bonus and equity incentive plan.

Company

hirify.global is a drug discovery and development company using machine learning and large-scale data to develop predictive disease models, therapeutics, patient biomarkers, and clinical strategies.

What you will do

• Design and implement a phase-appropriate Quality Management System covering document control, deviations, CAPAs, and change control.
• Author core SOPs and develop training programs for research and operations teams.
• Lead the quality lifecycle and vendor audits for CROs, CMOs, and CDMOs performing GLP, GCP, and GMP work.
• Partner with Compute, Data Science, and data engineering teams to validate AI/ML models, maintain data lineage, and protect data integrity.
• Develop regulatory-friendly monitoring for evolving algorithms, including model drift documentation and continuous validation.
• Advise leadership and cross-functional stakeholders on compliance with FDA, EMA, and global regulations while overseeing operational and business risks.

Requirements

• 10+ years of quality assurance experience in biotech or pharma, including supporting a small company through clinical entry.
• Expert knowledge of GLP, GCP, and GMP regulations.
• Extensive experience conducting vendor audits and preparing for regulatory inspections.
• Working knowledge of Computer System Validation and the ability to discuss data pipelines and controls with software and IT engineers.
• Ability to build quality processes from the ground up, write SOPs and reports, and tailor systems to the company’s development stage.
• US-based applicants are targeted, with regular in-person attendance required in South San Francisco.

Culture & Benefits

• Annual performance bonus and equity incentive plan eligibility.
• 401(k) plan with employer matching.
• Medical, dental, vision, mental health, and well-being support.
• Flexible vacation policy and paid parental leave.
• Quarterly budget for books and online courses, plus support for relevant professional conferences.
• Home-office, cell phone, and internet stipends, with onsite meals, baristas, and commuter bus access for onsite and hybrid employees.