Senior Specialist, Quality Assurance

Location: Louisville, Colorado, United States; primarily onsite, with remote work when appropriate

Salary: $105,060–$129,780 per year

Company

hirify.global is a biotechnology company developing an integrated immunotherapy platform and off-the-shelf cancer therapies.

What you will do

• Provide Quality Assurance oversight during site start-up and routine cGMP manufacturing operations.
• Partner with Manufacturing, Process Sciences, Engineering, Facilities, Quality Control, Supply Chain, Regulatory Affairs, and other functions to maintain compliance.
• Review and approve Master Batch Records, SOPs, work instructions, specifications, and other controlled GMP documents.
• Review and approve deviations, CAPAs, and change controls, while supporting investigations and implementation activities.
• Provide quality subject matter expertise for material controls, batch record review, and product disposition.
• Develop and manage quality-system KPIs and provide on-the-floor quality support.

Requirements

• Bachelor’s degree in biochemistry, molecular and cellular biology, immunology, biology, or a related life sciences or technical discipline.
• At least 8 years of experience in an FDA-regulated industry.
• Strong knowledge of cGMP requirements, quality systems, good documentation practices, and data-integrity principles.
• Ability to assess quality and compliance risks independently and make timely, risk-based decisions.
• Strong technical writing, investigation, analytical, problem-solving, communication, and cross-functional collaboration skills.
• Ability to work primarily onsite, including in laboratories, manufacturing areas, and clean rooms; occasional nights and weekends may be required.

Nice to have

• Experience with viral-vector, cell-therapy, gene-therapy, biologics, or aseptic manufacturing.
• Experience with batch record review and product disposition.
• Knowledge of FDA regulations, EU GMP requirements, ICH guidelines, and applicable industry standards.
• Experience participating in cGMP audits and inspections.

Culture & Benefits

• Medical, dental, and vision insurance plans.
• 401(k) plan with a 100% company match on the first 4% of employee deferrals.
• Paid time off, commuter benefits, and a cell phone stipend.
• Work in new facilities in Louisville and Seattle while contributing to cancer immunotherapy development.