Global GxP Quality Director: Inspection Readiness

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

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.