Director, QA Operations — cGMP & Cell Therapy, Equity

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

Benefits offered by this job

Competitive compensation package

Annual cash bonus

Equity / ESPP

401(k) with company match

Health, dental, vision insurance

Paid time off

Job summary

Adicet Bio, Inc. in Redwood City, CA, seeks a Director of Quality Assurance Operations to build and lead the QA Ops team and ensure cGxP compliance across clinical and regulatory activities.

The role partners with Manufacturing, Facilities, QC, Regulatory, and other functions, driving continuous improvement and supporting regulatory submissions and audits. Strong leadership and planning are essential.

Qualifications

• Bachelor’s Degree in life sciences.
• 10+ years in life sciences with 6+ years in QA.
• 5+ years in direct management.
• Strong knowledge of cGMP regulations and quality systems.
• Experience with Health Authority inspections.
• Experience with regulatory submissions and quality-related sections.
• Willingness to travel.

Responsibilities

• Ensure cGMP compliance for clinical manufacturing and regulatory alignment.
• Oversee batch records, in-process/release, and stability testing.
• Review development activities for GMP preparedness.
• Lead quality risk management and validation programs.
• Serve as team lead in investigations, change controls and risk assessments.
• Collaborate with facilities and SMEs on equipment qualifications.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

Quality systems

Project planning

Communication skills

Education

Bachelor’s Degree in life sciences

Tools

LIMS

eQMS

Job description

Adicet Bio, Inc. in Redwood City, CA, seeks a Director of Quality Assurance Operations to build and lead the QA Ops team and ensure cGxP compliance across clinical and regulatory activities.

The role partners with Manufacturing, Facilities, QC, Regulatory, and other functions, driving continuous improvement and supporting regulatory submissions and audits. Strong leadership and planning are essential.