Quality Assurance Manager, Operations (Biotech)

Location: Based in Portsmouth, NH

Company

hirify.global is a global leader in life sciences, operating 30+ sites across five continents to manufacture the medicines of tomorrow.

What you will do

• Lead and manage a team of QA Compliance Specialists and QA Project Managers to deliver quality objectives.
• Act as a point of escalation for quality-related issues impacting internal and external stakeholders.
• Ensure strict alignment with GMP regulations, customer Quality Agreements, and internal SOPs.
• Partner cross-functionally with Manufacturing, MSAT, Engineering, QC, and Supply Chain to resolve complex quality issues.
• Participate in key quality forums, including Change Control, Deviations Review Board, and CAPA Board.
• Oversee quality metrics and perform lot release and disposition activities in accordance with GMP standards.

Requirements

• 5–10 years of QA experience within biotechnology, pharmaceutical, or regulated manufacturing environments.
• Proven experience managing, coaching, and developing professional teams.
• Strong expertise in GMP regulations, quality systems, and compliance requirements.
• Experience leading investigations, deviations, CAPA, and change control processes.
• Ability to influence decision-making within a matrixed organizational structure.
• Must be based in the Portsmouth, NH office.

Nice to have

• Experience with TrackWise, SAP, Syncade, and Microsoft Office tools.

Culture & Benefits

• Performance-related bonus.
• Comprehensive medical, dental, and vision insurance.
• 401(k) matching plan.
• Life, short-term, and long-term disability insurance.
• Paid time off (PTO) and employee assistance programs.