QA Operations Director — Biotech (Hybrid, cGMP)

Adicet Bio, Inc; Redwood City (CA); On-site; USD 199,000 - 274,000; Full time

Benefits offered by this job

Competitive compensation package

401(k) with Roth and ESPP

Generous PTO and holidays

Onsite gym and facilities

Job summary

Adicet Bio, Inc. is seeking a Director of Quality Assurance Operations to build and lead the QA Ops team at our Redwood City, CA headquarters.

This role works across Manufacturing, QC, Supply Chain, Regulatory, and IT to ensure cGxP compliance for clinical development and commercialization. The ideal candidate will bring 10+ years in life sciences with deep QA experience, including FDA inspections, LIMS/eQMS proficiency, and strong leadership to drive continuous improvement.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 10+ years in life sciences with 6+ years in QA.
• 5+ years of direct management experience.
• Mastery of cGMP regulations and quality systems.
• Experience with Health Authority inspections and regulatory submissions.

Responsibilities

• Ensure cGMP compliance for clinical manufacturing and adherence to 21 CFR Parts 210, 211, ICH and EU GMPs.
• Oversee lot disposition, release, and stability testing with cross-functional partners.
• Review development activities for GMP readiness including studies and reports.
• Lead Quality Risk Management and participate in investigations, change controls and risk assessments.
• Support equipment qualification, lifecycle management, and training programs.

Skills

Interpersonal communication

Planning

Organizational skills

Multitasking

Travel flexibility

Education

Bachelor's Degree in life sciences

Tools

LIMS

eQMS

Job description

Adicet Bio, Inc. is seeking a Director of Quality Assurance Operations to build and lead the QA Ops team at our Redwood City, CA headquarters.

This role works across Manufacturing, QC, Supply Chain, Regulatory, and IT to ensure cGxP compliance for clinical development and commercialization. The ideal candidate will bring 10+ years in life sciences with deep QA experience, including FDA inspections, LIMS/eQMS proficiency, and strong leadership to drive continuous improvement.