Manager, Quality Assurance (Operations)

Location: Portsmouth, NH, United States — on-site

Company

hirify.global operates globally connected life sciences manufacturing sites focused on producing medicines and supporting customers' breakthrough therapies.

What you will do

• Lead the QA Operations Batch Record Review team and oversee timely, compliant batch record review and release support.
• Recruit, train, coach, and develop QA professionals while managing workload, resources, and performance.
• Assess quality and compliance observations, including severity and requirements for quality records.
• Partner with Manufacturing to resolve batch record and electronic batch record observations.
• Review and approve deviations, CAPAs, investigations, change controls, effectiveness checks, extensions, and other quality records.
• Support batch disposition, inspection readiness, quality strategy, continuous improvement, and Quality Management System effectiveness across cross-functional teams.

Requirements

• Bachelor's degree in a scientific discipline.
• 5–10 years of Quality Assurance experience in a GMP-regulated pharmaceutical, biotech, or life sciences environment.
• Experience leading, mentoring, coaching, and developing direct reports.
• Strong knowledge of GMP regulations, quality systems, deviations, CAPAs, investigations, and change controls.
• Experience supporting regulatory inspections, customer audits, and quality compliance activities.
• Strong communication, decision-making, problem-solving, and stakeholder management skills; experience with TrackWise, SAP, Syncade, and Microsoft Office is preferred.

Culture & Benefits

• Agile career environment and dynamic working culture.
• Opportunities to lead, mentor, and develop quality professionals.
• Exposure to complex biologics manufacturing and quality operations.
• Collaboration with Manufacturing, QC, Engineering, MSAT, and Supply Chain teams.
• Medical, dental, and vision insurance, performance-based compensation programs, and leadership development opportunities.