Global Head of Quality Assurance & Compliance - Biotech

Quetzal; Northern (KY); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Medical benefits

PTO & holidays

Flexible spending accounts

Job summary

Quetzal Therapeutics seeks a Senior Director of Quality to lead the Quality function, build a phase-appropriate QMS, and support global clinical development and regulatory submissions. This role reports to the CRQO and partners with Regulatory Affairs, Clinical Operations, CMC, and external partners to ensure GxP compliance.

The ideal candidate combines strategic judgment with hands-on execution, managing quality processes in a lean, fast-paced biotech environment and influencing

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10+ years of progressive Quality Assurance experience in biotech/pharma.
• Experience leading QA programs/teams in clinical development.
• Experience with Phase 1–3 programs and regulatory inspections.
• Knowledge of ICH, GCP, GMP and global GxP regulations.
• Experience auditing CROs, CMOs, labs and GxP providers.

Responsibilities

• Lead and manage Quality Assurance function.
• Develop and execute the Quality strategy aligned with milestones.
• Advise CRQO and provide executive-quality updates.
• Promote a culture of quality, compliance and continuous improvement.
• Set up and maintain an effective QMS and SOP framework.
• Oversee supplier qualification and vendor quality oversight.
• Lead inspection readiness planning and regulatory interactions.
• Mentor and scale the Quality organization as the company grows.

Skills

Quality leadership

Regulatory collaboration

Risk-based decision making

Cross-functional influence

Quality metrics & CI

Education

Bachelor's in Life Sciences/Related

Advanced degree (MS/PhD/PharmD/MPH)

Tools

eQMS

GxP Compliance Programs

Job description

Quetzal Therapeutics seeks a Senior Director of Quality to lead the Quality function, build a phase-appropriate QMS, and support global clinical development and regulatory submissions. This role reports to the CRQO and partners with Regulatory Affairs, Clinical Operations, CMC, and external partners to ensure GxP compliance.

The ideal candidate combines strategic judgment with hands-on execution, managing quality processes in a lean, fast-paced biotech environment and influencing