QA/QC Manager - DPF

Location: Christiansburg, Virginia, United States; on-site role

Company

hirify.global is a public benefit biotechnology and pharmaceutical company developing therapies for rare diseases and technologies for manufacturing transplantable organs.

What you will do

• Lead the on-site Quality Assurance and QC Microbiology function at the designated pathogen-free facility supporting xenotransplantation organ manufacturing.
• Govern environmental monitoring programs for barrier and non-barrier areas, including qualification, trending, signal detection, and continuous improvement.
• Lead deviation, CAPA, root cause analysis, change control, complaint, and quality record activities using electronic quality systems.
• Support regulatory and clinical programs, product development, technology transfer, scale-up, validation, and inspection readiness.
• Manage supplier qualification, internal and vendor audits, corrective actions, and audit documentation.
• Establish quality metrics and dashboards, analyze risks and trends, and present performance to senior Quality leadership.

Requirements

• 8+ years of experience in a GMP/QSR-regulated environment with a bachelor's degree, or 6+ years with a master's degree.
• Applied expertise in cGMP, GMP/QSR, FDA regulations, GxP principles, environmental monitoring governance, and QC microbiology operations.
• Experience supporting FDA, USDA, EMA, ISO, and other regulatory inspections as a subject matter expert.
• Experience reviewing and approving controlled documents, deviations, CAPAs, change controls, and quality records in electronic quality systems.
• Experience leading root cause analysis for microbiological and environmental events and applying risk-based decision-making, including ICH Q9 principles.
• Strong analytical judgment, problem-solving, risk assessment, communication, and quality record review skills.

Nice to have

• Experience contributing to IND, IDE, or BLA submissions.
• Experience with TrackWise and MasterControl.
• Experience creating and implementing a QMS.
• Experience leading organizational change related to quality systems and compliance.

Culture & Benefits

• Mission-driven work focused on unmet medical needs and expanding the availability of transplantable organs.
• Benefits may include medical, dental, vision, and prescription coverage.
• Employee wellness resources, 401(k), and ESPP savings plans are available to eligible employees.
• Paid time off, paid parental leave, disability benefits, and additional programs are available to eligible employees.