Director, Sterility Assurance

Location: United States — Morristown, New Jersey — Remote

Company

hirify.global is a global life sciences organization supporting the development and manufacture of therapies across a network spanning five continents.

What you will do

• Lead the global sterility assurance and contamination control strategy across sterile drug substance and drug product operations.
• Develop biological contamination control strategies covering viral, bacterial, fungal, mycoplasma, endotoxin, and other adventitious agent risks.
• Direct risk assessments, contamination event responses, root-cause investigations, CAPAs, and sustainable gap-closure initiatives.
• Harmonize standards and procedures for facility and equipment design, environmental monitoring, microbiological testing, cleaning, disinfection, material transfer, and segregation controls.
• Provide sterility assurance expertise for product development, technology transfer, new product introductions, network expansion, and facility start-ups.
• Coach employees and support regulatory inspections, customer audits, GQC audits, mock pre-approval inspections, and due diligence activities.

Requirements

• Bachelor's, Master's, or higher degree in Microbiology, Pharmaceutical Sciences, Life Sciences, Biotechnology, Engineering, or a related scientific discipline.
• Significant leadership experience in sterile pharmaceuticals, biotechnology, biologics, cell and gene therapy, or another GMP-regulated environment.
• Deep expertise in sterility assurance, contamination control, microbiology, aseptic processing, and quality risk management.
• Experience supporting complex investigations, contamination events, and regulatory inspections.
• Proven ability to influence and lead within global, matrixed organizations.
• Expert knowledge of sterile manufacturing regulations and industry standards, with strong communication, coaching, and stakeholder management skills.

Culture & Benefits

• Purpose-driven work contributing to therapies that improve and save lives.
• Global collaboration across hirify.global's manufacturing network.
• Culture focused on innovation, collaboration, continuous learning, and scientific excellence.
• Opportunity to make a meaningful impact on a global scale.