Director, Quality Assurance Operations (Biotechnology)

Location: Redwood City, California; onsite at least three days per week, Tuesday–Thursday mandatory

Salary: $199,000–$274,000 USD annually

Company

hirify.global is a clinical-stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer.

What you will do

• Build and lead the Quality Assurance Operations team and coordinate with internal functions and external consultants or contractors.
• Ensure cGMP compliance for Phase I, II, and III clinical manufacturing, including applicable FDA, ICH, and EU GMP requirements.
• Oversee lot disposition, batch record review, release and stability testing, quality events, raw material release, and GMP product or facility issues.
• Lead quality investigations, risk assessments, change controls, validation programs, equipment qualifications, and lifecycle management.
• Represent the organization during third-party audits and health authority inspections.
• Develop quality procedures, programs, and policies; support quality-related regulatory submissions and continuous improvement initiatives.

Requirements

• Bachelor’s degree in life sciences or a related scientific discipline.
• 10+ years of experience in life sciences, biotechnology, pharmaceuticals, or another regulated therapeutic environment, including 6+ years in Quality Assurance.
• 5+ years of direct management experience.
• Mastery of cGMP regulations, quality systems, and applicable FDA CFR, EMA, ICH, ISO, and other global requirements.
• Experience with health authority inspections and electronic management systems such as LIMS and eQMS.
• Strong communication, planning, organization, multitasking, and cross-functional collaboration skills; travel as required.

Nice to have

• Prior cell therapy experience.

Culture & Benefits

• Collaborative, high-performing environment with a strong focus on in-person engagement.
• Annual cash bonus, long-term incentives, equity, Employee Stock Purchase Plan, and 401(k) with a 4.5% company match.
• Medical, dental, vision, FSA, HSA, life, disability, legal, pet, and other insurance programs.
• Paid time off, company holidays, winter break, sick time, and paid parental leave.
• State-of-the-art office with an onsite gym, parking and EV charging, Caltrain shuttle, subsidized lunches, and stocked breakrooms.