GMP Quality Assurance Director, eQMS Lead

Judo Bio; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account

401(k)

Mobility stipend

Transportation benefit

Unlimited PTO

Company holidays

Recharge break

Job summary

Judo Bio is seeking a Director of Quality Assurance to lead GMP and quality systems across outsourced manufacturing and testing. The role will drive eQMS implementation, document control, CAPA, and audit readiness within a growing biotech environment.

The candidate should bring 10+ years in pharma/biotech QA, strong GMP knowledge, and proven leadership to build scalable quality processes and support regulatory submissions and clinical development.

Qualifications

• Bachelor’s degree in a scientific, engineering, or related discipline.
• More than 10 years of pharmaceutical or biotechnology QA experience, with leadership.
• Strong GMP knowledge and familiarity with FDA, EU, and ICH guidance.
• Hands-on experience implementing and administering an eQMS.
• Experience overseeing outsourced GMP manufacturing and testing, supplier audits, and change control.

Responsibilities

• Develop, implement, and maintain a QMS suitable for the company’s development stage.
• Oversee document control, training, deviations, investigations, CAPA, change control, risk management, and audits.
• Lead eQMS implementation, validation, and rollout as the business owner.
• Provide QA oversight of contract manufacturing, testing, and related GMP activities.
• Coordinate with internal teams to support milestones, regulatory submissions, and inspections.
• Foster a culture of quality and continuous improvement across functions.

Skills

GMP knowledge

Regulatory knowledge

Leadership

Quality mindset

Project management

Communication

Strategic thinking

Analytical thinking

Education

Bachelor’s degree in science or engineering

Job description

Judo Bio is seeking a Director of Quality Assurance to lead GMP and quality systems across outsourced manufacturing and testing. The role will drive eQMS implementation, document control, CAPA, and audit readiness within a growing biotech environment.

The candidate should bring 10+ years in pharma/biotech QA, strong GMP knowledge, and proven leadership to build scalable quality processes and support regulatory submissions and clinical development.