Executive Director, QA Sterility Assurance (Biotech)

Location: Onsite in East Greenbush, New York, United States; Monday–Friday, 8:00 a.m.–4:30 p.m.

Salary: $203,000–$399,400 annually

Company

hirify.global develops life-changing medicines for people with serious diseases through science and innovation.

What you will do

• Lead the strategy, design, implementation, and continuous improvement of the GMP Contamination Control Strategy across aseptic and low-bioburden manufacturing operations.
• Provide technical direction for environmental monitoring, cleanroom classification, personnel qualification, gowning practices, and aseptic process simulations.
• Lead or influence investigations and risk assessments involving microbial excursions, sterility failures, and environmental monitoring deviations, including corrective and preventive actions.
• Monitor program performance through operational metrics such as environmental monitoring trends, excursion rates, and media fill success rates.
• Apply quality risk management tools, including FMEA, fishbone analysis, and contamination risk mapping, to identify and mitigate contamination vectors.
• Represent contamination control and sterility assurance expertise to senior leadership, health authorities, manufacturing functions, and external partners.

Requirements

• Bachelor’s degree in Microbiology, Molecular Biology, Biology, Pharmaceutical Sciences, or a related scientific discipline, or an equivalent combination of education and experience.
• 18+ years of progressive experience for the Executive Director level in pharmaceutical or biopharmaceutical microbiology, sterility assurance, or contamination control, including significant leadership experience in aseptic manufacturing; level may be determined by experience.
• Deep operational expertise in aseptic processing and low-bioburden manufacturing, including cleanroom design and classification, HVAC airflow principles, personnel and material flow, gowning qualification, and aseptic technique.
• Hands-on ownership of Contamination Control Strategies, environmental monitoring program design and trending, aseptic process simulation, deviation management, CAPA, and failure investigations.
• Expert knowledge of EU Annex 1, FDA aseptic processing guidance, USP <1116>, PIC/S, and ISO 14644, with experience representing contamination control positions during FDA, EMA, or MHRA inspections.
• Strong people leadership, cross-functional collaboration, executive communication, judgment, and decision-making skills in high-stakes situations affecting product disposition and patient safety.

Nice to have

• Advanced degree in a relevant scientific discipline.

Culture & Benefits

• Onsite work environment with a focus on collaboration across QA Operations, Manufacturing, Facilities/Engineering, and Microbiology Labs.
• Comprehensive total rewards package may include annual bonuses, equity awards, retirement benefits, 401(k) company match, health and wellness programs, insurance, paid time off, and family support benefits.
• Inclusive workplace and equal opportunity employment practices.