Manager GMP Quality Operations (AI)

TL;DR

Manager GMP Quality Operations (AI): Providing QA support for manufacturing operations of Cell & Genetic Therapeutic programs with an accent on compliance, data integrity, and digitized quality systems. Focus on developing AI-enabled solutions for backlog triage, metrics generation, and records reconciliation to improve operational efficiency.

Location: Must be based in Boston, MA (On-site 5 days per week)

Salary: $118,400 - $177,600

Company

hirify.global is a global biotechnology company focused on scientific innovation.

What you will do

• Provide QA support for Cell and Gene Therapy manufacturing operations and analytical laboratories.
• Oversee Quality Systems across CDMOs, focusing on CAPA, change control, and risk management.
• Develop and maintain quality metrics, dashboards, and reports using Python, Power BI, and Smartsheet.
• Identify compliance risks and gaps in GMP processes and implement mitigating controls.
• Design AI-enabled solutions for backlog triage, records reconciliation, and archiving to enhance traceability.
• Lead cross-functional projects to drive continuous improvement and inspection readiness.

Requirements

• Bachelor's degree in a Business or Sciences field.
• 5+ years of QA experience in a GMP-regulated environment.
• Demonstrated experience providing QA support to GMP manufacturing operations.
• Hands-on experience with ATMPs (cell/gene therapy) or Biologicals/sterile products.
• Proven ability to design and deliver AI-driven solutions for quality operations.
• Experience with network-based applications such as Oracle, TrackWise, or Veeva.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Generous paid time off including company-wide summer and winter shutdowns.
• Educational assistance programs and student loan repayment support.
• 401(k) retirement plan with company matching.
• Supportive environment with a focus on professional growth and wellbeing.