Director, Quality Assurance Operations
Adicet Bio, Inc
August 19, 2026
Remote friendly (Redwood City, CA)
United States
Operations
Director, Quality Assurance Operations
Key Responsibilities
- Ensure cGMP compliance for clinical manufacturing (phase I/II/III) and compliance with 21 CFR Parts 210/211, ICH Guidelines, and EU GMPs as applicable.
- Accountable for lot disposition: batch record review, in-process/release, stability testing review, and oversight of quality events related to GMP product/process/facility.
- Review and approve development activities in preparation for GMP (e.g., development studies/reports, engineering activities).
- Champion Quality Risk Management Program; lead phase-appropriate validation program.
- Lead quality discussions, investigations, risk assessments, and change controls to resolve product quality issues.
- Partner with Facilities and SMEs on equipment qualification and lifecycle management.
- Manage cGxP training program with Quality Systems.
- Represent organization during third-party audits/inspections.
- Provide technical guidance for investigations (quality deviations, laboratory investigations, change controls), including tracking, follow-up, and liaison with investigation writers for timely resolution.
- Oversee raw material program including raw material QA release.
- Develop and implement QA procedures/programs/policies to ensure cGxP compliance.
- Support regulatory submissions of quality-related sections.
- Drive continuous improvement initiatives.
Qualifications
- Bachelor’s degree in scientific/relevant life sciences discipline.
- 10+ years in life sciences (biotech/pharma or regulated therapeutic environment), including 6+ years in Quality Assurance.
- 5+ years direct management experience.
- Mastery of cGMP regulations and quality systems.
- Thorough knowledge of FDA CFR, EMA, ICH, ISO, and other global regulations.
- Experience with Health Authority Inspections.
- Proficiency with electronic management systems (e.g., LIMS, eQMS).
- Strong written/oral communication and planning/organization/multitasking.
- Travel as required. Prior cell therapy experience is a plus.
Key Responsibilities
- Ensure cGMP compliance for clinical manufacturing (phase I/II/III) and compliance with 21 CFR Parts 210/211, ICH Guidelines, and EU GMPs as applicable.
- Accountable for lot disposition: batch record review, in-process/release, stability testing review, and oversight of quality events related to GMP product/process/facility.
- Review and approve development activities in preparation for GMP (e.g., development studies/reports, engineering activities).
- Champion Quality Risk Management Program; lead phase-appropriate validation program.
- Lead quality discussions, investigations, risk assessments, and change controls to resolve product quality issues.
- Partner with Facilities and SMEs on equipment qualification and lifecycle management.
- Manage cGxP training program with Quality Systems.
- Represent organization during third-party audits/inspections.
- Provide technical guidance for investigations (quality deviations, laboratory investigations, change controls), including tracking, follow-up, and liaison with investigation writers for timely resolution.
- Oversee raw material program including raw material QA release.
- Develop and implement QA procedures/programs/policies to ensure cGxP compliance.
- Support regulatory submissions of quality-related sections.
- Drive continuous improvement initiatives.
Qualifications
- Bachelor’s degree in scientific/relevant life sciences discipline.
- 10+ years in life sciences (biotech/pharma or regulated therapeutic environment), including 6+ years in Quality Assurance.
- 5+ years direct management experience.
- Mastery of cGMP regulations and quality systems.
- Thorough knowledge of FDA CFR, EMA, ICH, ISO, and other global regulations.
- Experience with Health Authority Inspections.
- Proficiency with electronic management systems (e.g., LIMS, eQMS).
- Strong written/oral communication and planning/organization/multitasking.
- Travel as required. Prior cell therapy experience is a plus.