Head of US Quality Assurance (Biotech)

Location: Pennington, New Jersey, United States

Salary: $190K–$250K annually, depending on experience and skill set.

Company

hirify.global is a biotechnology company providing research and development services and biological building blocks for healthcare and life sciences. ProBio, a hirify.global subsidiary, is a global CDMO supporting plasmid, antibody, and cell and gene therapy development and manufacturing.

What you will do

• Lead the US Quality Assurance organization and provide strategic quality leadership across CDMO manufacturing operations.
• Develop and continuously improve the Quality Management System, including deviations, CAPA, change control, document control, quality 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 compliance and inspection readiness for FDA, customer, and other regulatory inspections and audits.
• Lead customer quality activities, including Quality Agreements, customer audits, investigations, and issue resolution.
• Partner with Manufacturing, Process Development, Engineering, Validation, Supply Chain, Project Management, and Commercial teams while driving continuous improvement.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related scientific discipline; an advanced degree is preferred.
• 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, with experience leading regulatory inspections and customer audits.
• Strong leadership, communication, strategic thinking, and stakeholder management skills.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match fully vested on day one.
• 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, legal assistance, and supplemental insurance plans.
• Commuter benefits, well-being initiatives, and peer-to-peer recognition programs.