Senior GLP QA Lead — Nonclinical Compliance & Audits

Sword Bio Limited; Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Job summary

Sword Bio Limited is seeking an experienced GLP Quality Assurance Manager to lead our GLP QA program and ensure compliance with global GLP regulations across nonclinical studies.

The role requires extensive regulatory expertise, people leadership, and the ability to influence quality culture throughout the organization. You will work with scientific and operations teams to maintain the highest QA standards.

Qualifications

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, or related field.
• 8+ years of experience in GLP Quality Assurance within CRO/pharma/biotech/medical device.
• Minimum 3 years of people leadership experience.
• Strong knowledge of FDA 21 CFR Part 58, OECD GLP, and ICH guidance.
• Experience with electronic Quality Management Systems (eQMS).
• Knowledge of computerized system validation (CSV) principles.

Responsibilities

• Lead the GLP Quality Assurance program in accordance with FDA 21 CFR Part 58 and global regulations.
• Oversee QA personnel and conduct independent inspections and audits.
• Manage regulatory inspections and partner with scientific/operational teams to ensure quality and compliance of nonclinical studies.
• Influence quality culture across the organization and support operational excellence.

Skills

Regulatory expertise

Leadership

Quality assurance

Communication

GLP knowledge

Education

Bachelor's degree in Biology/ Chemistry/ Pharmaceutical Sciences or related field

Tools

eQMS

CSV principles

Job description

Sword Bio Limited is seeking an experienced GLP Quality Assurance Manager to lead our GLP QA program and ensure compliance with global GLP regulations across nonclinical studies.

The role requires extensive regulatory expertise, people leadership, and the ability to influence quality culture throughout the organization. You will work with scientific and operations teams to maintain the highest QA standards.