Senior Director, GxP Quality Assurance

Haya Therapeutics SA; San Diego (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Haya Therapeutics SA in San Diego, CA seeks a senior Quality leader to design, scale, and lead a phase-appropriate QMS across GLP, GCP, and GMP. You will ensure continuous regulatory inspection readiness and robust vendor oversight to support clinical drug product compliance.

You will oversee QRM, deviation investigations, CAPA, Change Control, and CSV to ensure data integrity and compliance for FDA/EMA aligned programs, enabling timely IND/CTA submissions and product approvals.

Qualifications

• Bachelor’s or Master’s degree in Biology, Chemistry, Pharmacy, or related scientific discipline.
• Multi-Modality GxP mastery across GLP, GCP, GMP regulations for diverse product types.
• Regulatory interpretation and operational implementation of US CFRs, ICH guidelines, EMA directives, PMDA requirements.
• Experience preparing for and leading regulatory inspections (PAI, BIMO) and contributing to CMC filings.
• External CDMO/vendor governance with quality agreements and KPI setting.
• Facility/engineering compliance knowledge including IQ/OQ/PQ and EU FDA requirements.

Responsibilities

• Design, scale, and lead enterprise-quality system (eQMS) across GLP, GCP, GMP.
• Oversee QRM, deviation investigations, CAPA, Change Control across R&D, Clinical, Manufacturing.
• Lead global vendor governance, audits, and Quality Agreements with CDMOs/CROs.
• Direct inspection readiness activities for health authority interactions (PAI, BIMO).
• Manage CSV/data integrity frameworks (21 CFR Part 11, ALCOA+) across records.
• Oversee batch record review, PSF preparation, and disposition with QPs/RPs.

Skills

GxP Mastery

Regulatory CFRs

QMS Leadership

Vendor Governance

Inspection Readiness

CAPA & Deviation

CSV & Data Integrity

Cross-Functional Leadership

Education

Bachelor’s or Master’s in Biology/ Chemistry/ Pharmacy

Tools

eQMS systems

Change Control systems

Job description

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.