Senior Director, GxP Quality Assurance

Job overview

The Senior Director, GxP Quality Assurance role is onsite in San Diego, CA. Compensation is not specified. HAYA Therapeutics’ mission is to transform patient care through RNA-based therapeutics. The director establishes and leads a phase-appropriate quality management system across GLP, GCP, and GMP domains to maintain inspection readiness, oversee vendors, and support clinical drug product compliance. The role aligns quality practices across research, clinical, and manufacturing teams to protect program timelines and support regulatory submissions and product approvals.

What you'll do

• Establish and scale an enterprise eQMS across GLP, GCP, and GMP
• oversee quality risk management, deviations, CAPA, and change control
• direct GxP vendor management and audits
• lead inspection readiness and health authority interactions
• manage computerized system validation and data integrity frameworks
• oversee batch record review and disposition pathways with Qualified Persons and Responsible Persons.

What we're looking for

Skills & competencies

senior director

gxp quality assurance

san diego ca

haya therapeutics

glp

gcp

gmp

quality management system

eqms

regulatory compliance

vendor audits

inspection readiness

Work arrangement

• Weekend coverage required

Why this role

The role spans GLP, GCP, and GMP quality oversight, including vendor audits, regulatory inspection readiness, and clinical drug product compliance.

About the employer

HAYA Therapeutics is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.