Sr Manager QA - QVTS (Biotech)

Location: Holly Springs, North Carolina, United States

Salary: $144,021.45–$194,852.55 annually

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses.

What you will do

• Lead Quality oversight for the design, installation, commissioning, qualification, and process qualification of a new facility and equipment.
• Partner with Manufacturing, Facilities & Engineering, and support functions throughout construction, facility start-up, operational readiness, and operations.
• Provide quality and compliance guidance on cGMP processes, procedures, protocols, assays, documents, records, and quality systems.
• Review, approve, and track documentation including work orders, deviations, CAPAs, and change controls.
• Drive continuous improvement and ensure alignment with applicable regulations, Good Manufacturing Practices, Good Documentation Practices, safety, and control requirements.
• Build and manage a Quality team, investigate deviations, and represent the Quality unit during audits and inspections.

Requirements

• High school diploma/GED with 12 years of Quality and/or Operations experience, or an associate’s degree with 10 years, bachelor’s degree with 8 years, master’s degree with 6 years, or doctorate with 2 years.
• At least 2 years of experience managing people or leading teams, projects, programs, or resource allocation.
• Experience in or strong understanding of biologics drug substance operations.
• Strong understanding of regulatory requirements, industry standards, and risk-based decision-making.
• Previous experience overseeing commissioning, qualification, and validation.
• Strong communication, collaboration, coaching, and team leadership capabilities.

Nice to have

• Two or more years of management experience at a senior Quality level.
• Experience driving improvement and partnering across an enterprise or network.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off, work-life balance support, and career development opportunities.
• Sponsorship is not guaranteed for this role.