Associate Director, Quality Data Science (Biotech)

TL;DR

Associate Director, Quality Data Science (Biotech): Leading the Quality Data Science and Quality Engineering function to implement applied statistics and machine learning strategies for an allogeneic CAR T platform with an accent on GMP operations and product quality control. Focus on developing data-driven insights, process validation, and establishing a robust quality data science roadmap to accelerate product development.

Location: Must be based in or able to work hybrid in South San Francisco, CA. Candidates must be authorized to work in the U.S.

Salary: $170,000–$210,000 per year

Company

hirify.global is a clinical-stage biotechnology company pioneering the development of allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Develop and execute a strategy to establish quality data science as a core capability for platform knowledge and predictive analytics.
• Drive strategies for process and analytical understanding, including product comparability, validation, and stability trending.
• Contribute to the GMP Quality Management System by developing procedures and supporting management review tools.
• Serve as the company authority on quality data science for regulatory submissions and inspections.
• Support root cause investigations and champion data-driven decision-making across the enterprise.
• Collaborate with cross-functional teams to develop a comprehensive Knowledge Management approach.

Requirements

• BS/MS in Statistics, Data Science, or related field with 6-8 years of experience in biotech or pharma.
• Strong expertise in applied statistics including DoE, multivariate analysis, and time-series.
• Hands-on experience with R, Python, JMP, or SAS.
• Comprehensive knowledge of GMP regulations and industry best practices.
• Proven success influencing cross-functional teams and senior stakeholders.
• Must be authorized to work in the U.S.

Nice to have

• Advanced degree in a relevant field.
• ASQ Quality Engineer certification.

Culture & Benefits

• Collaborative environment with talented professionals in the biotechnology space.
• Competitive compensation package including annual performance bonus and equity.
• Comprehensive health insurance and generous time off policies.
• Two annual company-wide holiday shutdowns.