Senior Specialist, Quality Assurance Operations (Gene Therapy)

Location: Bedford, Massachusetts, United States; primarily on-site. Wednesday–Saturday schedule with four 10-hour workdays, starting between 7:00 a.m. and 8:30 a.m.

Annual salary: $105,300–$130,100 USD, plus eligibility for an annual bonus and equity incentives.

Company

hirify.global develops innovative medicines for rare diseases, including gene therapy products.

What you will do

• Review and approve master and executed drug substance production batch records.
• Provide QA approval for drug substance area shutdowns and restarts following maintenance or environmental monitoring events.
• Conduct routine manufacturing area walkthroughs, logbook reviews, and inspection-readiness assessments.
• Write, review, and approve SOPs, work instructions, policies, standards, and manufacturing documentation.
• Partner with Manufacturing, Engineering, Validation, QC, Quality Systems, and MSAT to resolve deviations and assess product and compliance impact.
• Drive investigations and continuous improvement initiatives that reduce waste and improve manufacturing efficiency.

Requirements

• Bachelor’s degree in a scientific field such as microbiology, chemistry, or biochemistry.
• At least 5 years of experience in biopharmaceutical, biotechnology, cell therapy, or gene therapy industries in Manufacturing and Quality roles.
• Direct experience at a biologics or advanced therapy medicinal product manufacturing site.
• Knowledge of drug substance manufacturing, aseptic practices, and domestic and international GMP regulations.
• Ability to communicate technical information and complex situations clearly to site management and health authority inspectors.
• Ability to work on-site in a controlled manufacturing environment, including GxP gowning, protective equipment, physical activity, and potential respirator use.

Culture & Benefits

• Vacation time and company-observed public holidays.
• Volunteer days and employee wellbeing benefits.
• Long-term incentive and employee stock purchase plans or equivalent offerings.
• Fitness reimbursement, tuition sponsorship, and professional development plans.
• Benefits vary by region and country.