Manager, GMP Supplier Quality Management

Location: RTP, NC, United States

Company

hirify.global is a publicly traded biotechnology and pharmaceutical company developing therapies for rare diseases and technologies to expand the availability of transplantable organs.

What you will do

• Manage and continuously improve the Supplier Quality Management program across all company sites in alignment with FDA pharmaceutical and combination-product regulations.
• Execute risk-based supplier qualification, approval, requalification, and disqualification processes with business partners and the GMP Auditing team.
• Assess vendor risks and support annual audit scheduling based on supplier performance, material criticality, regulatory history, quality-system maturity, and business continuity risk.
• Establish and maintain supplier Technical and Quality Agreements, including quality, compliance, change-control, notification, and documentation responsibilities.
• Monitor supplier performance through KPIs, scorecards, trend analysis, management reviews, and escalation processes.
• Coordinate vendor deviations, nonconformances, OOS events, CAPA, change notifications, material holds, corrective action requests, recalls, and regulatory inspection support.

Requirements

• 8+ years of quality assurance experience with a bachelor's degree, 6+ years with a master's degree, or 2+ years with a PhD/PharmD.
• 5+ years of vendor oversight experience and 2+ years of direct people management or leadership experience.
• Strong technical knowledge of pharmaceutical or GMP-regulated operations and the ability to interpret technical, quality, regulatory, and manufacturing documentation.
• Knowledge of cGMP, 21 CFR Parts 210 and 211, FDA QMSR, ISO 13485, ISO 14971, EU Medical Device Regulation, and relevant ICH guidance.
• Experience with supplier qualification, risk management, quality agreements, audits, performance monitoring, and regulatory or quality-system inspections.
• Excellent written and verbal communication skills, including preparation of quality agreements, procedures, executive summaries, and inspection responses.

Nice to have

• ASQ Certified Quality Auditor or Certified Quality Manager certification.
• Experience with MS Office, DocuSign, electronic quality management systems, and AI applications for supplier quality management.
• Experience leading cross-functional teams, influencing without direct authority, and managing competing priorities.

Culture & Benefits

• Mission-driven environment focused on unmet medical needs and innovation in rare-disease therapies and transplantable organs.
• Eligible employees may receive medical, dental, vision, prescription, wellness, savings-plan, 401(k), and ESPP benefits.
• Benefits also include paid time off, paid parental leave, and disability coverage.
• Work emphasizes enthusiasm, creativity, persistence, and unconventional problem-solving.