Senior Quality Assurance Specialist (GMP)

Location: North Carolina; onsite 5 days per week

Salary: $80,000–$86,000 per year, plus incentive bonus, equity compensation, and benefits.

Company

hirify.global is a clinical-stage biotechnology company developing investigational therapies for cancer and rare diseases, including TARA-002 and IV Choline Chloride.

What you will do

• Review GMP documents and records, including SOPs, batch records, protocols, reports, deviations, CAPAs, change controls, and training records.
• Assess documentation against GMP requirements, approved procedures, data integrity principles, and quality system standards.
• Identify compliance, inspection, and quality risks and provide risk-based remediation feedback to document owners and cross-functional partners.
• Review analytical testing, laboratory investigations, certificates of analysis, and facility, utility, equipment, and computer qualification documentation.
• Track review activities and remediation deliverables, support inspection readiness and audits, and maintain documentation packages for regulatory review.
• Support product, technology, and material transfers and participate in oversight of CMOs, laboratories, and third-party service providers.

Requirements

• Bachelor’s degree in biology, chemistry, microbiology, biotechnology, pharmaceutical sciences, engineering, quality, or a related discipline; equivalent experience may be considered.
• 5+ years of experience in Quality Assurance, Quality Systems, Document Control, Manufacturing Quality, or a related GMP-regulated environment.
• Experience supporting clinical manufacturing operations, batch release activities, analytical testing, and quality control operations.
• Strong experience with change controls, deviations, investigations, CAPAs, controlled documents, and quality system processes.
• Working knowledge of current GMP requirements, good documentation practices, data integrity expectations, and risk-based remediation.
• Proficiency in MS Office Suite, strong attention to detail, sound judgment, communication skills, and the ability to manage multiple priorities.

Culture & Benefits

• Friendly, open, team-oriented culture that values diverse perspectives.
• Cross-functional commitment to improving patients’ lives and maintaining a strong quality culture.
• Flexible working hours and schedule.
• Generous paid holidays and unlimited PTO.
• Medical, dental, vision, commuter, fertility, matching 401(k), equity, and incentive bonus benefits.