Senior Director, GxP Quality Assurance

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.
• Manage computerized system validation (CSV to 21 CFR Part 11 / EU Annex 11) and data integrity (ALCOA+) frameworks across analytical, clinical, and manufacturing records to protect asset valuation and trial validity.
• Oversee batch record review,