Associate Director, Shift Quality Operations (Biotech)

TL;DR

Associate Director, Shift Quality Operations (Biotech): Providing quality leadership and oversight for cell therapy manufacturing operations with an accent on cGMP compliance, aseptic processing, and real-time shop floor quality management. Focus on leading cross-functional teams, managing deviations and CAPA, and ensuring inspection readiness in a high-stakes regulated environment.

Location: Must be based in Boston, MA (On-Site)

Salary: $153,900–$230,900

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Provide shift-based QA oversight for aseptic manufacturing, including formulation, filling, and inspection.
• Lead and develop a team of quality professionals to ensure real-time shop floor compliance.
• Manage deviation triage, root cause analysis, impact assessments, and CAPA development.
• Ensure manufacturing activities adhere to cGMP, GDP, and Contamination Control Strategy (CCS) standards.
• Partner with cross-functional teams including Manufacturing, Engineering, and Supply Chain to support batch execution and continuous improvement.
• Maintain a constant state of inspection readiness for regulatory and client audits.

Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, or Engineering.
• 8+ years of industry experience in manufacturing, QA, or QC within a regulated pharmaceutical environment.
• 5+ years of experience supporting aseptic manufacturing, sterile operations, or parenteral production.
• Strong knowledge of cGMP regulations, Annex 1, and contamination control concepts.
• Proven ability to lead improvement projects using tools like Root Cause Analysis, LEAN, or Six Sigma.
• Must be able to work on-site five days per week in Boston, MA.

Nice to have

• Master’s degree in a relevant discipline.
• Prior people leadership or supervisory experience.
• Experience with shop floor QA oversight in commercial or late-stage clinical manufacturing.
• Familiarity with digital quality systems (MES, LIMS, eQMS) and data visualization tools.

Culture & Benefits

• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs, including student loan repayment.
• 401(k) retirement plan with company matching.
• Supportive environment focused on professional growth and work-life balance.