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, PSF preparation, and disposition pathways in collaboration with Qualified Persons (QPs) and Responsible Persons (RPs) to ensure compliant global investigational drug supply and distribution under MIA/WDA licenses
RequirementsRequired Knowledge and ExperienceEssential Qualifications & Technical Capabilities (Must-Haves)- Education: Bachelor's or Master's degree in Biology, Chemistry, Pharmacy, or a related scientific discipline.
- Multi-Modality GxP Mastery: Comprehensive technical depth across GLP, GCP, and GMP regulations encompassing synthetic molecules, biologics, vaccines, and advanced human cell and tissue-based products (HCT/P / ATMPs).
- Regulatory Interpretation: Demonstrated capability interpreting and operationalizing US FDA CFRs (Parts 58, 210, 211, 312, 820, 1271, 600), ICH guidelines, EMA directives, and PMDA requirements using a risk-based, fit-for-purpose strategy.
- Inspection & Filing Track Record: Proven expertise preparing organizations for and leading successful regulatory health authority inspections (PAI, BIMO) and contributing to CMC Module 3 regulatory filings (IND/NDA/BLA/J-BLA).
- External CDMO/Vendor Governance: Advanced capability negotiating Quality Agreements, setting Quality Performance Indicators (QPIs), and conducting global audits across CDMO, CRO, and specialized testing facilities.
- Facility & Engineering Compliance: Practical knowledge overseeing sterile facility commissioning, qualification (IQ/OQ/PQ), and utility design under EU Annex 1 and FDA requirements.
Desirable Experience & Specialized Expertise (Nice-to-Haves)- Experience providing strategic quality oversight for RNA therapeutics, oligonucleotides, or novel cellular delivery platforms.
- Demonstrated expertise conducting M&A due diligence, in/out-licensing asset reviews, and preparing companies for strategic transactions or public offerings.
Leadership ProfileThe successful candidate will demonstrate:
- Autonomy & Strategic Scope: Operates with complete executive latitude for tactical and strategic decision-making, setting the enterprise quality vision and aligning priorities across corporate leadership.
- Enterprise Impact & Vision: Drives overall enterprise value by establishing robust compliance frameworks that protect IP, accelerate clinical asset milestones, and enhance corporate reputation with health authorities and investors.
- Pragmatic Problem Solving: Translates complex GxP non-conformances into structured root-cause analyses and risk-based solutions without imposing unnecessary bureaucratic friction on scientific teams.
- Cross-Functional Authority & Alignment: Bridges technical regulatory demands with , building cross-functional trust and fostering an integrated culture of quality.
