Executive Director, GMP Quality Assurance

Artiva Biotherapeutics•San Diego, CA

10d•Onsite

About The Position

The Executive Director, GMP Quality Assurance leads Artiva Biotherapeutics’ internal GMP quality operations and compliance program, ensuring that cell therapy products manufactured and tested for clinical use meet all applicable FDA, EMA, and other global health authority requirements. This role owns the quality systems governing internal GMP manufacturing, batch disposition, deviations, CAPA, change control, and inspection readiness, and partners closely with Technical Operations (GMP and Technical Development) and Regulatory Affairs. The Executive Director builds and leads the GMP QA operations organization, sets quality policy and standards, and drives a culture of quality and continuous improvement across the company. This position operates with a high degree of independence, exercising broad judgment in interpreting regulations and resolving complex compliance issues, and reports to the VP of Quality.

Requirements

15+ years of progressive GMP quality assurance experience in biologics, cell therapy, or pharmaceutical manufacturing, including 8+ years in a senior quality leadership role.
Bachelor’s degree in life sciences, chemistry, engineering, or a related field required.
Deep working knowledge of GMP regulations (21 CFR Parts 210/211, ICH Q7/Q9/Q10) and direct, hands-on experience hosting FDA and other health authority inspections.
Primary role in successful BLA and PLI.
Proven track record building and leading GMP QA operations teams and quality systems within a growing biotech or biopharmaceutical company.
Strong knowledge of batch disposition, deviation/CAPA management, change control, and annual product review processes.
Excellent leadership, communication, and cross-functional collaboration skills, with the ability to influence at all levels of the organization.
Demonstrated ability to work independently, exercise sound judgment on complex compliance matters, and make risk-based decisions with minimal oversight.
Ability to travel occasionally as needed; ability and willingness to work on-site in San Diego, CA.

Nice To Haves

Advanced degree or relevant certification (e.g., ASQ CQA, RAC) a plus.
Experience with cell therapy, biologics, or other advanced therapy medicinal products (ATMPs) strongly preferred.

Responsibilities

Lead GMP Quality Assurance operations, including document control, training, and material release - ensuring consistent, compliant, and timely execution across the quality system.
Lead GMP Quality Assurance compliance, including deviations/investigations, CAPA, change control, complaint handling, and annual product quality reviews.
Oversee batch record review and approval, and intermediate and final product disposition for internally manufactured and tested clinical materials.
Chair recurring GMP quality governance meetings, including the Material Review Board, Change Control Board, and other quality forums, driving timely and risk-based decision-making.
Ensure ongoing compliance of internal GMP manufacturing and testing operations with FDA, EMA, and other applicable global health authority requirements, including 21 CFR Parts 210/211 and ICH Q7/Q9/Q10.
Serve as the primary quality lead for FDA and other health authority inspections and internal audits of internal manufacturing and testing operations. Lead inspection readiness activities.
Help prepare the company for a successful Biologics License Application (BLA), including pre-BLA quality gap assessments, CMC quality documentation, and readiness for pre-approval inspection, and support other regulatory submissions (e.g., IND) with quality data related to internal GMP operations.
Partner with Technical Operations and Regulatory Affairs to provide quality oversight of technology transfer, process validation, and product/process lifecycle changes.
Own and maintain the GMP QA risk register, proactively identifying, assessing, and tracking mitigation of quality and compliance risks across internal GMP operations.
Drive risk-based quality decision-making, and lead escalation and resolution of critical quality events that may impact product supply, data integrity, or patient safety.
Build and lead the GMP QA compliance and operations team, providing day-to-day supervision of staff, including hiring, mentoring, professional development, and performance management.
Establish and maintain GMP QA policies, procedures, and quality metrics; report quality performance, risk trends, and inspection readiness status to executive leadership and the Quality System Management Review board on a regular basis.
Champion a culture of quality, compliance, and continuous improvement throughout the organization.