Senior Director, Manufacturing Technical Sciences Quality Assurance (Biotech)

TL;DR

Senior Director, Manufacturing Technical Sciences Quality Assurance (Biotech): Leading end-to-end technical quality oversight for cell and genetic therapy programs throughout clinical development and commercialization with an accent on CMC standards, regulatory compliance, and lifecycle management. Focus on building quality frameworks, managing complex technical change, and mentoring cross-functional teams to ensure operational excellence.

Location: Must be based in or able to commute to Boston, MA (Hybrid: 3 days/week on-site)

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Lead and implement quality compliance principles across the Cell & Genetic Therapies portfolio.
• Establish CMC and Analytical Quality standards for product lifecycle deliverables.
• Provide QA oversight for technical change management and analytical development activities.
• Serve as the Quality SME for technical transfers and new product introductions.
• Manage stability programs to ensure compliance with internal procedures and global regulatory standards.
• Lead, mentor, and develop a team of process and analytical QA personnel.

Requirements

• Bachelor's or Master's degree in a biotech, life science, or engineering discipline.
• 15+ years of industry experience in manufacturing, QA, or QC within a regulated pharmaceutical environment.
• Minimum 10 years of leadership experience managing teams or resources.
• In-depth knowledge of global regulatory agencies (ICH, EU, FDA) and GXP lifecycle.
• Proven experience with NDA, BLA, or MAA submissions and health authority inspections.
• Ability to work on-site in Boston, MA at least 3 days per week.

Culture & Benefits

• Inclusive market-leading benefits including medical, dental, and vision coverage.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• Educational assistance programs and student loan repayment support.
• 401(k) retirement plan with company matching.
• Commuting subsidy and charitable donation matching.