Executive Director, GMP Quality Assurance
Artiva Biotherapeutics
August 20, 2026
On-site
San Diego, CA
Operations
Job Summary:
The Executive Director, GMP Quality Assurance leads internal GMP quality operations and the compliance program to ensure cell therapy products meet applicable FDA, EMA, and other global health authority requirements. Own quality systems for internal GMP manufacturing, batch disposition, deviations, CAPA, change control, and inspection readiness; partner with Technical Operations and Regulatory Affairs. Sets quality policy/standards and drives a culture of quality and continuous improvement. Reports to the VP of Quality.
Duties/Responsibilities:
- Lead GMP Quality Assurance operations (document control, training, material release).
- Lead GMP QA compliance (deviations/investigations, CAPA, change control, complaint handling, annual product quality reviews); oversee batch record review/approval and intermediate/final product disposition.
- Chair GMP quality governance meetings (Material Review Board, Change Control Board, and other quality forums).
- Ensure internal manufacturing/testing compliance with FDA/EMA requirements, including 21 CFR Parts 210/211 and ICH Q7/Q9/Q10.
- Serve as primary quality lead for health authority inspections and internal audits; lead inspection readiness.
- Support BLA readiness (quality gap assessments, CMC quality documentation, pre-approval inspection) and assist IND/regulatory submissions with quality data.
- Provide quality oversight for technology transfer, process validation, and lifecycle changes.
- Own/maintain GMP QA risk register; drive risk-based decisions and resolve critical quality events impacting supply, data integrity, or patient safety.
- Build/lead GMP QA team (hiring, mentoring, development, performance management).
- Establish/maintain GMP QA policies, procedures, and quality metrics; report performance, risk trends, and inspection readiness.
Requirements:
- 15+ years GMP QA experience in biologics/cell therapy/pharma; 8+ years in senior quality leadership.
- BS in life sciences/chemistry/engineering or related; advanced degree or certifications (e.g., ASQ CQA, RAC) a plus.
- Deep GMP knowledge (21 CFR 210/211, ICH Q7/Q9/Q10) and hands-on inspection hosting experience; primary role in successful BLA and PLI.
- Track record building/leading GMP QA teams and quality systems.
- Experience with cell therapy/biologics/ATMPs strongly preferred.
- Strong knowledge of batch disposition, deviation/CAPA, change control, annual product review.
- Excellent leadership, communication, and cross-functional collaboration.
- Ability to work independently, use sound judgment, and make risk-based decisions.
- Occasional travel; willingness to work on-site in San Diego, CA.
Benefits (explicitly listed): Medical, Dental, Vision; Group Life Insurance; Long Term Disability (LTD); 401(k); EAP; FSA; PTO; company-paid holidays (year-end holiday week); Bonus.ly recognition program.
Compensation (explicitly listed): Base salary $270,000–$290,000 (varies by level/skills/experience).
The Executive Director, GMP Quality Assurance leads internal GMP quality operations and the compliance program to ensure cell therapy products meet applicable FDA, EMA, and other global health authority requirements. Own quality systems for internal GMP manufacturing, batch disposition, deviations, CAPA, change control, and inspection readiness; partner with Technical Operations and Regulatory Affairs. Sets quality policy/standards and drives a culture of quality and continuous improvement. Reports to the VP of Quality.
Duties/Responsibilities:
- Lead GMP Quality Assurance operations (document control, training, material release).
- Lead GMP QA compliance (deviations/investigations, CAPA, change control, complaint handling, annual product quality reviews); oversee batch record review/approval and intermediate/final product disposition.
- Chair GMP quality governance meetings (Material Review Board, Change Control Board, and other quality forums).
- Ensure internal manufacturing/testing compliance with FDA/EMA requirements, including 21 CFR Parts 210/211 and ICH Q7/Q9/Q10.
- Serve as primary quality lead for health authority inspections and internal audits; lead inspection readiness.
- Support BLA readiness (quality gap assessments, CMC quality documentation, pre-approval inspection) and assist IND/regulatory submissions with quality data.
- Provide quality oversight for technology transfer, process validation, and lifecycle changes.
- Own/maintain GMP QA risk register; drive risk-based decisions and resolve critical quality events impacting supply, data integrity, or patient safety.
- Build/lead GMP QA team (hiring, mentoring, development, performance management).
- Establish/maintain GMP QA policies, procedures, and quality metrics; report performance, risk trends, and inspection readiness.
Requirements:
- 15+ years GMP QA experience in biologics/cell therapy/pharma; 8+ years in senior quality leadership.
- BS in life sciences/chemistry/engineering or related; advanced degree or certifications (e.g., ASQ CQA, RAC) a plus.
- Deep GMP knowledge (21 CFR 210/211, ICH Q7/Q9/Q10) and hands-on inspection hosting experience; primary role in successful BLA and PLI.
- Track record building/leading GMP QA teams and quality systems.
- Experience with cell therapy/biologics/ATMPs strongly preferred.
- Strong knowledge of batch disposition, deviation/CAPA, change control, annual product review.
- Excellent leadership, communication, and cross-functional collaboration.
- Ability to work independently, use sound judgment, and make risk-based decisions.
- Occasional travel; willingness to work on-site in San Diego, CA.
Benefits (explicitly listed): Medical, Dental, Vision; Group Life Insurance; Long Term Disability (LTD); 401(k); EAP; FSA; PTO; company-paid holidays (year-end holiday week); Bonus.ly recognition program.
Compensation (explicitly listed): Base salary $270,000–$290,000 (varies by level/skills/experience).