Senior Director, Head of Quality Control (Cell Therapy)

Location: Boston, MA, United States. Hybrid: remote work up to two days per week, or on-site five days per week with ad hoc flexibility.

Salary: $216,000–$324,000 per year, plus annual bonus and equity awards.

Company

hirify.global is a global biotechnology company focused on scientific innovation and patient outcomes.

What you will do

• Lead Quality Control strategy and external QC oversight for stem cell therapy manufacturing and testing partners.
• Oversee outsourced release, in-process, raw material, stability, microbiology, and environmental monitoring testing.
• Lead method transfer, assay implementation, laboratory readiness, and performance governance for CDMOs and contract testing laboratories.
• Manage QC investigations, assay performance trends, data review expectations, and testing-related escalations.
• Partner with QA, Manufacturing, MSAT, Analytical Development, Supply Chain, and Regulatory teams to maintain supply continuity and analytical readiness.

Requirements

• Advanced degree in Biology, Cell Biology, Molecular Biology, Biochemistry, Analytical Chemistry, Bioengineering, Pharmaceutical Sciences, or a related scientific discipline.
• Typically 15+ years of relevant industry experience in biotechnology, biopharmaceutical, stem cell therapy, cell therapy, or other advanced therapy environments.
• 8+ years of progressive people leadership experience, including leadership of managers and cross-functional teams.
• Deep experience with GMP QC operations, method transfer, method qualification and validation, assay lifecycle management, laboratory investigations, data integrity, regulatory expectations, and inspection readiness.
• Experience overseeing cell-based, molecular, microbiological, or potency-related methods across internal and external laboratories.
• Strong ability to influence Manufacturing, Quality Assurance, Analytical Development, Regulatory, and technical operations functions.

Nice to have

• PhD in a relevant scientific discipline.
• Experience building or scaling QC organizations for late-stage clinical or commercial manufacturing.
• Experience with external testing laboratories, CDMOs, or distributed manufacturing and testing networks.
• Familiarity with LIMS, electronic laboratory systems, digital data review tools, and QC laboratory automation.
• Experience supporting regulatory submissions, health authority responses, and inspection management.

Culture & Benefits

• Continuous learning focused on advances in AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits, paid time off, and company shutdowns in summer and winter.
• Educational assistance, student loan repayment, commuting subsidy, charitable donation matching, and 401(k).
• Inclusive workplace with equal employment opportunity and reasonable accommodation support.