Manager, Supplier Quality Management (Biotech)

TL;DR

Manager, Supplier Quality Management (Biotech): Managing the supplier qualification program and quality agreement negotiations for clinical-stage cell therapy development with an accent on regulatory compliance and cross-functional collaboration. Focus on developing quality agreement templates, facilitating negotiations, and ensuring adherence to FDA/EMA/ICH guidelines.

Location: Must be authorized to work in the US

Salary: $70.00–$80.00 per hour

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

• Manage supplier questionnaires, including content improvement and response evaluation.
• Develop and maintain quality agreement templates with standard and fallback terms.
• Conduct and facilitate quality agreement negotiations with suppliers.
• Perform periodic reviews of quality agreements.
• Assist in supplier qualification and monitoring activities.
• Support departmental process improvement initiatives and special projects.

Requirements

• Bachelor’s degree in Engineering, Chemistry, or Biological Sciences.
• Prior experience in quality assurance, SQM, manufacturing, or quality engineering.
• Proven experience in quality agreement negotiation and management.
• Extensive knowledge of US FDA GMP, GCP, EMA, and ICH guidelines.
• Must be authorized to work in the US.
• Proficiency in MS Office suite.

Nice to have

• Experience with Veeva systems.

Culture & Benefits

• Collaborative and fast-paced biotechnology environment.
• Comprehensive benefits package including health insurance.
• Annual performance bonus and equity opportunities.
• Generous time off policy including two annual company-wide shutdowns.