QA Manager, GLP Quality Assurance

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

Company Description

At Sword Bio, we are a leading Contract Research Organization (CRO) dedicated to providing high-quality nonclinical research services that accelerate the development of innovative therapeutics. Our commitment to scientific excellence, regulatory compliance, and client satisfaction has established us as a trusted partner across the pharmaceutical and biotechnology industries.

We are seeking an experienced GLP Quality Assurance Manager to lead our Quality Assurance program and ensure compliance with global Good Laboratory Practice (GLP) regulations while supporting operational excellence across our nonclinical studies.

Role Summary

The GLP Quality Assurance Manager is responsible for managing the organization's GLP Quality Assurance program in accordance with FDA 21 CFR Part 58, and other applicable global regulatory requirements. This individual will oversee QA personnel, conduct independent inspections and audits, manage regulatory inspections, and partner with scientific and operational teams to ensure the integrity, quality, and compliance of nonclinical studies. This leadership role requires strong regulatory expertise, exceptional communication skills, and the ability to influence quality culture across the organization.

Required Qualifications

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
• 8+ years of experience in GLP Quality Assurance within a CRO, pharmaceutical, biotechnology, or medical device environment.
• Minimum 3 years of people leadership experience.
• Extensive knowledge of:
• FDA 21 CFR Part 58
• OECD Principles of GLP
• ICH guidance (where applicable)
• Experience with electronic Quality Management Systems (eQMS).
• Knowledge of computerized system validation (CSV) principles
• Strong understanding of nonclinical and bioanalytical laboratory operations.
• Demonstrated experience managing Quality Management Systems.
• Excellent written and verbal communication skills.

Preferred Qualifications

• RQAP-GLP certification (Society of Quality Assurance) preferred.
• Experience leading regulatory inspections.
• Experience in bioanalysis, toxicology, pathology, analytical chemistry, or pharmacology studies.
• Lean Six Sigma certification is a plus.