Head of US Quality Assurance (Biotech)

Location: Pennington, New Jersey, United States

Salary: $190,000–$250,000 per year, depending on experience and skill set.

Company

hirify.global is a biotechnology and life sciences company providing research, manufacturing, biologics CDMO, and cell therapy services to customers worldwide.

What you will do

• Lead the US Quality Assurance organization and provide strategic direction across CDMO operations.
• Develop and continuously improve the Quality Management System, including deviations, CAPA, change control, document control, risk management, and training compliance.
• Provide QA oversight for GMP manufacturing, process development, technology transfer, validation, qualification, batch record review, and product release.
• Maintain regulatory inspection readiness and lead responses to FDA, customer, and other audits.
• Lead customer quality activities, including Quality Agreements, customer audits, investigations, and issue resolution.
• Coach the QA team, monitor quality metrics, manage risks, and drive continuous improvement with cross-functional partners.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related scientific discipline.
• 10+ years of progressive Quality leadership experience in biotechnology, pharmaceutical, or CDMO environments.
• Experience with Quality Management Systems, Quality Operations, and Quality Risk Management.
• Experience supporting biologics, plasmid DNA, viral vectors, cell and gene therapy, or other GMP manufacturing operations.
• Extensive knowledge of FDA, EMA, ICH, and global GMP regulations, including experience leading regulatory inspections and customer audits.
• Strong leadership, communication, strategic thinking, and stakeholder management skills.

Nice to have

• Master’s degree or Ph.D. in a relevant scientific discipline.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match fully vested on the first day.
• Paid parental leave after three months of employment.
• Paid vacation, personal, sick, floating holiday, and company holiday time.
• Flexible spending and health savings accounts, life and disability insurance, commuter benefits, well-being initiatives, and peer recognition programs.