Director, QA for QC

Location: Cambridge, Massachusetts, United States; hybrid work arrangement

Base salary: $213,063–$260,411 USD per year, plus performance-based annual bonus and equity compensation.

Company

hirify.global develops curative genome editing treatments for severe and life-threatening diseases.

What you will do

• Provide strategic, technical, and operational quality oversight for QC activities covering drug substance and drug product release, stability, specialized testing, and lifecycle management.
• Govern analytical control strategies, specifications, reference standards, critical reagents, method validation, method transfers, and analytical method lifecycle management.
• Lead data-driven trending, control charting, multivariate analysis, and predictive quality initiatives using stability, release, and in-process testing data.
• Oversee external laboratory investigations, including OOS, OOT, atypical results, deviations, and data integrity events, ensuring effective CAPAs through closure.
• Support regulatory submissions, health authority inspections, audits, and remediation activities as the QC quality subject-matter expert.
• Recruit, manage, mentor, and develop QA personnel supporting QC oversight while strengthening capabilities for commercial GMP operations.

Requirements

• 10–12 years of relevant industry experience, including commercial QC activities and phase-appropriate GMP testing of cell and gene therapies or biologics.
• Advanced degree in Chemistry, Molecular or Cell Biology, Pharmaceutical Sciences, Biotechnology, Engineering, or a related scientific discipline; MS or PhD preferred.
• Expertise in qualification, validation, transfer, and lifecycle management of analytical methods, with technical understanding of HPLC/UPLC, CE, compendial methods, UV, bioassay, and gel electrophoresis.
• Experience with stability programs, in-house reference standards, laboratory operations, electronic systems such as EDMS and LIMS, and data analysis tools including JMP, MINITAB, GraphPad Prism, or PLA.
• Knowledge of FDA, ICH, USP/NF, EP, and JP requirements, plus experience with health authority inspections, IND or BLA filings for ATMP or biologic products, observations, and CAPAs.
• Prior direct or indirect people-management experience and the ability to lead cross-functional work in a matrix environment.

Culture & Benefits

• Work in a mission-driven environment focused on curative genome editing treatments.
• Collaborate across Analytical Development, Process Development, Manufacturing Sciences, QA GMP Operations, Regulatory Affairs, and external laboratories and CMOs.
• Participate in a hybrid work arrangement with expectations for time on site.
• Receive performance-based annual cash bonus and new-hire equity grant eligibility.
• Access company benefits and opportunities for professional development through mentoring and technical coaching.