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, 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

Required Knowledge and Experience

Essential 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 Profile

The 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.

HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development.

At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics.

Notice to Recruitment Agencies & Search Firms:

HAYA Therapeutics operates a Preferred Supplier List (PSL) and manages all recruitment directly through our Human Resources team. We do not accept unsolicited resumes or speculative CVs from third-party agencies, search firms, or recruiters. Any unsolicited candidates or CVs submitted through non-approved channels, directly to HAYA employees, or without a fully executed recruitment agreement in place will be considered property of HAYA Therapeutics. HAYA Therapeutics will not pay any fee, liability, or finder's fee for candidates submitted under these circumstances.