layiq
/la·yiq/adjective
worthy; deserving; fitting; suitable.
A role, opportunity, or path that merits attention, time, and pursuit.
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Job opportunity
Senior Director, GxP Quality Assurance
HAYA Therapeutics
San Diego, CA, US
Source: HAYA Therapeutics careers · View original posting
- Employment
- full time
Employer job description
From HAYA Therapeutics's posting. “We” and “our” refer to the employer.
Purpose:
Design, build, scale, and lead HAYA’s phase-appropriate Quality Management System across GLP, GCP, and GMP domains to ensure continuous regulatory inspection readiness, robust vendor oversight, and clinical drug product compliance.
Accountabilities
Establish and scale an enterprise-wide electronic Quality Management System (eQMS) across GLP, GCP, and GMP functional areas to maintain continuous audit-readiness across FDA, EMA, and other global regulatory frameworks.
Oversee quality risk management (QRM), deviation investigations, CAPA, and Change Control workflows across cross-functional R&D, Clinical, and Manufacturing teams to resolve operational non-conformances and safeguard program timelines.
Direct the global GxP vendor management and audit program across CDMOs, CROs, and testing laboratories to ensure strict compliance with regulatory dossiers and executed Quality Agreements.
Lead inspection readiness initiatives and serve as the responsive quality lead for health authority interactions (PAI and BIMO) for pre-IND, CTA, BLA, and NDA submissions to secure timely clinical trial authorizations and product approvals.