Senior Director, Quality Systems and Compliance (Biotech)

Location: Hybrid in South San Francisco, California, with remote work permitted up to two days per week. Candidates must be authorized to work in the United States.

Salary: $230,000–$270,000 per year, plus annual performance bonus and equity.

Company

hirify.global is a clinical-stage biotechnology company developing allogeneic CAR T cell products for cancer and autoimmune disease.

What you will do

• Lead the Quality Management System and ensure compliance with cGMP and global regulatory standards.
• Define and execute the global compliance strategy for clinical development programs approaching commercialization.
• Lead internal inspection readiness, supplier audits, regulatory inspections, and health authority compliance interactions.
• Manage compliance risk assessments and remediation of findings, deviations, and CAPA.
• Oversee supplier quality compliance and risk management programs.
• Advance digital quality solutions, continuous improvement initiatives, metrics, and KPIs while building and coaching a high-performing team.

Requirements

• Bachelor’s degree in Biological Sciences, Chemistry, or Engineering; an advanced degree is preferred.
• 10–12 years of experience in the pharmaceutical or biotechnology industry, including 5–6 years of management experience focused on Quality Systems and Compliance.
• In-depth knowledge of US and EU Quality Management System requirements for pharmaceutical and biotech manufacturing.
• Experience leading regulatory inspections with global health authorities; Pre-License Inspection or Pre-Approval Inspection experience is a plus.
• Strong interpersonal and communication skills, with the ability to convey findings to senior management.
• US work authorization is required.

Culture & Benefits

• Collaborative environment with cross-functional partnership across Manufacturing, Regulatory, and Clinical Quality Assurance.
• Health insurance and generous time off.
• Two annual company-wide holiday shutdowns.
• Annual performance bonus and equity.
• Equal opportunity workplace focused on diversity, inclusion, and continuous improvement.