Senior Quality Systems Specialist (Biotech)

Location: Cambridge, MA; on-site

Salary: $107,100–$138,600 per year

Company

hirify.global is a clinical-stage biotechnology company developing genetically engineered, human-compatible organs to address the global organ shortage.

What you will do

• Develop, implement, and maintain quality systems supporting GMP manufacturing and testing for clinical-study materials.
• Initiate, manage, and close deviations and CAPAs across multiple sites.
• Administer the Electronic Laboratory Notebook for batch records and test methods.
• Manage documentation, archival of physical records, document change controls, and organizational training programs.
• Develop and report quality metrics while supporting cross-functional teams in resolving manufacturing quality issues.
• Review and approve executed quality records, improve processes, and support special QA projects.

Requirements

• Bachelor’s degree in a relevant scientific or operational life sciences or biopharma discipline and 5+ years of quality systems experience; candidates without a degree may qualify with 7+ years of relevant GLP/GMP experience.
• Knowledge of Quality Management Systems, CAPA processes, and audit procedures.
• Familiarity with ISO, FDA, cGMP, and related regulatory standards.
• Strong analytical, problem-solving, communication, mentoring, and training skills.
• Proficiency with QA software and electronic Quality Management Systems is advantageous.

Nice to have

• Experience with Qualio, Veeva, or Benchling.
• Experience working in a start-up or small-company environment.

Culture & Benefits

• Work in a collaborative, cross-functional clinical-stage biotechnology environment.
• Contribute to the development of engineered organs and clinical manufacturing quality systems.
• Work alongside teams spanning development, manufacturing, quality control, and quality assurance.