Director, QA Operations — cGMP Compliance & Cross-Functional Leadership

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

Benefits offered by this job

Onsite gym

Free shuttle (Caltrain)

Company-subsidized lunches

401(k) with Roth

Equity incentives

Employee Stock Purchase Plan (ESPP)

Job summary

Adicet Bio, Inc. seeks a Director of Quality Assurance Operations to build and lead the QA Operations team in Redwood City, CA.

You will ensure cGMP compliance for clinical manufacturing, manage disposition, deviations and investigations, and partner with Manufacturing, Facilities, QC, and Regulatory to support regulatory submissions. You will report to the VP of Quality Assurance, driving continuous improvement, cross-functional collaboration, and regulatory readiness for FDA/EMA submissions in

Qualifications

• Bachelor’s Degree in scientific or relevant disciplines in life sciences.
• 10+ years in the life sciences industry with 6+ years in QA.
• 5+ years of direct management experience.
• Mastery of cGMP regulations and quality systems.
• Thorough knowledge of FDA CFR, EMA, ICH, ISO requirements.
• Experience with Health Authority inspections.
• Proficiency with electronic management systems (LIMS, eQMS).
• Strong interpersonal and communication skills.

Responsibilities

• Ensure cGMP compliance for clinical manufacturing and regulatory alignment.
• Accountable for lot disposition, batch review and stability testing oversight.
• Lead QA operations with cross-functional collaboration across departments.
• Develop and manage validation, change controls, deviations, and investigations.
• Represent QA in third-party audits and inspections.
• Support regulatory submissions of quality sections.

Skills

Leadership

Project management

Communication

Quality mindset

Education

Bachelor’s Degree in life sciences

Tools

LIMS

eQMS

Job description

Adicet Bio, Inc. seeks a Director of Quality Assurance Operations to build and lead the QA Operations team in Redwood City, CA.

You will ensure cGMP compliance for clinical manufacturing, manage disposition, deviations and investigations, and partner with Manufacturing, Facilities, QC, and Regulatory to support regulatory submissions. You will report to the VP of Quality Assurance, driving continuous improvement, cross-functional collaboration, and regulatory readiness for FDA/EMA submissions in