Manager Quality Assurance (Biotechnology)

Location: Onsite in Holly Springs, North Carolina, United States; second-shift schedule including late afternoons and nights, typically 2:00 p.m.–10:30 p.m.

Salary: $118,235–$159,965 per year

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering human therapeutics for patients with serious illnesses.

What you will do

• Lead the PQA team during startup and transition to ongoing bulk drug substance manufacturing.
• Oversee readiness activities for facilities, utilities, equipment, systems, and processes.
• Hire, train, manage, and develop Quality Assurance staff, including schedules, priorities, performance, and ongoing support.
• Provide Quality oversight for GMP manufacturing, deviations, quality systems, compliance, and manufacturing investigations.
• Support inspection readiness, site audits, validation, change control, product release, and review and approval of manufacturing procedures.
• Partner with Manufacturing, Facilities & Engineering, and other functions to resolve issues, establish priorities, and deliver plant objectives.

Requirements

• Doctorate degree, or a master’s degree with 3 years of Quality experience.
• Bachelor’s degree with 5 years of Quality experience, associate’s degree with 10 years, or high school diploma/GED with 12 years.
• Direct people-management experience or leadership experience directing teams, projects, programs, or resource allocation.
• Experience in Quality, Manufacturing, Operational Excellence, Engineering, or Data/Information Systems.
• Ability to solve complex problems, evaluate scientific data, and make independent risk-based decisions on the manufacturing floor.
• Ability to work onsite in Holly Springs on a second-shift schedule, including late afternoons and nights.

Nice to have

• Experience with CDOCS, TrackWise, Maximo, LIMS, MES Werum, or similar systems.
• Knowledge of manufacturing investigations, CAPA, product release, validation, and change control.
• Experience managing competing priorities in a fast-paced environment.
• Strong technical writing, presentation, communication, coaching, and performance-management skills.

Culture & Benefits

• Career-development resources to expand skills and expertise.
• Diverse and inclusive workplace where employees are encouraged to contribute ideas.
• Total rewards covering health, financial security, work-life balance, and career benefits.
• Opportunity to support the launch of a new biomanufacturing facility incorporating digitalization and sustainability initiatives.