Associate Director, Project Quality - QC (Biotech)

Location: Kankakee, Illinois, United States; onsite at the hirify.global Kankakee site

Base salary: $154,000–$193,000 per year, excluding potential incentive compensation and equity.

Company

hirify.global is a global biotechnology company developing and delivering therapies, vaccines, and other products for rare diseases, immunology, hematology, respiratory, transplant, iron deficiency, and nephrology.

What you will do

• Lead QC strategy, governance, startup, qualification, validation, and operational readiness for the M7/M8 immunoglobulin manufacturing expansion.
• Build and lead a high-performing QC organization, including QC Analysts, a QC Sample Management Associate, and QCAT Associates.
• Direct facility design reviews, laboratory fit-out, equipment selection, workflow optimization, and laboratory qualification activities.
• Coordinate assay technology transfer and validation, environmental monitoring, qualification testing, equipment purchases, raw-material testing, engineering runs, process validation, PPQ, and commercial manufacturing support.
• Manage project roadmaps, timelines, budgets, resources, risks, deliverables, and change controls.
• Partner with Manufacturing, Engineering, Technical Operations, Validation, Global Quality, Regulatory Affairs, Supply Chain, suppliers, testing laboratories, and consultants.

Requirements

• Bachelor’s degree in biology, microbiology, chemistry, or another relevant scientific discipline; an advanced degree is preferred.
• 10+ years of experience in microbiological, biological, chemical, or biochemical analytics in a pharmaceutical or medicinal GMP environment.
• Significant laboratory management experience, including operations optimization and leadership of QC activities.
• Strong experience supporting regulatory inspections and customer audits.
• Extensive knowledge of analytical instruments and GxP regulations, with demonstrated management or leadership experience.
• Experience working in a global matrix organization and applying Six Sigma, Lean, or variability-reduction methods.

Culture & Benefits

• Work within a global biotechnology organization serving patients in more than 100 countries.
• Collaborate across scientific, manufacturing, quality, regulatory, engineering, and supply-chain functions.
• Benefits information is provided through hirify.global’s employee well-being program.
• Inclusive workplace focused on belonging, curiosity, empathy, and diverse perspectives.