Director, Quality Assurance

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 a Series A biotechnology company pioneering the delivery of oligonucleotide medicines to the kidney to treat systemic and renal diseases. Our proprietary STRIKE™ (Selectively Targeting RNA Into Kidney) platform leverages the kidney-specific megalin receptor to enable precise, cell-targeted delivery of RNA therapeutics. This innovative approach has the potential to unlock new treatment options for diseases that have historically been difficult to address.

We’re building a collaborative, science-driven organization that values curiosity, thoughtful execution, and the opportunity to tackle ambitious scientific challenges that can make a meaningful difference for patients.

Position Overview

Judo Bio is seeking an experienced Director, Quality Assurance to focus primarily on Good Manufacturing Practice (GMP) activities, including oversight of outsourced manufacturing, analytical testing, and product quality. The Director will also lead the implementation, administration, and ongoing improvement of an electronic Quality Management System (eQMS). Experience in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) is an asset, supporting quality oversight across the company’s clinical and nonclinical development activities

Reporting to SVP, Regulatory and Quality, the ideal candidate combines strategic leadership with hands‑on execution and can establish practical, scalable quality systems in a growing biotech organization.

How You’ll Contribute

Quality systems and eQMS

• Develop, implement, and maintain a Quality Management System (QMS) appropriate to the company’s development stage, product portfolio, and applicable regulatory requirements.
• Establish and oversee processes for document control, training, deviations, investigations, corrective and preventive actions (CAPA), change control, risk management, supplier qualification, and audits.
• Lead eQMS implementation and optimization, including requirements definition, workflow configuration, validation, and rollout.
• Serve as the eQMS business owner and administrator, managing user access, roles, workflows, controlled documents, training assignments, reporting, and system changes.
• Partner with IT and the eQMS vendor to maintain the system’s validated state, data integrity, security, and reliable access to quality records.
• Define quality metrics and lead management reviews to assess system effectiveness, identify trends, and drive continuous improvement.

GMP oversight

• Provide QA oversight of drug substance and drug product manufacturing, packaging, labeling, storage, distribution, and analytical testing performed by contract organizations.
• Qualify and oversee contract manufacturers, laboratories, and other GMP service providers through risk‑based assessments, audits, performance monitoring, and quality agreements.
• Review and approve GMP documentation, including specifications, master batch records, executed batch records, validation documentation, deviations, investigations, CAPA, and change controls, as appropriate.
• Oversee company batch disposition activities and coordinate with authorized release personnel, including Qualified Persons where applicable.
• Ensure quality events are investigated thoroughly, product and patient risks are assessed, and corrective actions are effective.
• Partner with CMC, Regulatory Affairs, Clinical Operations, and Supply Chain to support development milestones, technology transfers, regulatory submissions, and clinical supply readiness.
• Maintain inspection readiness and lead or support regulatory inspections, partner audits, and associated responses.
• Establish appropriate processes for stability oversight, product complaints, and recalls.

Leadership and cross functional collaboration

• Serve as the primary internal resource for GMP quality matters, providing clear, risk‑based guidance and timely escalation of significant issues.
• Build and manage internal and external quality resources, including consultants and service providers.
• Foster a culture of quality, accountability, and continuous improvement through training and cross‑functional engagement.
• Support GCP and GLP quality activities, including clinical and nonclinical vendor qualification, audit planning, and coordination with Clinical Operations, Nonclinical Development, and external quality specialists.

Qualifications

• Bachelor’s degree in a scientific, engineering, or related discipline; advanced degree preferred.
• 10 or more years of progressive pharmaceutical or biotechnology QA experience, including leadership responsibility.
• Strong working knowledge of GMP requirements and relevant FDA, EU, and ICH guidance.
• Demonstrated experience developing or substantially improving a QMS in a clinical‑stage or growing biotechnology organization.
• Hands‑on experience implementing and administering an eQMS, including computerized system validation and applicable electronic records and electronic signature requirements.
• Experience overseeing outsourced GMP manufacturing and testing, supplier audits, quality agreements, investigations, CAPA, and change control.
• Experience supporting regulatory inspections and maintaining inspection readiness.
• Strong judgment, communication, and organizational skills, with the ability to balance development timelines and quality requirements.
• Ability to work independently and manage both strategic priorities and detailed operational activities.

Preferred Qualifications

• GCP and/or GLP knowledge and experience supporting clinical or nonclinical quality oversight, contract research organization (CRO) qualification, or audits.
• Experience supporting early clinical development and the evolution of quality systems toward later‑stage development and commercialization.
• Experience building quality functions within a small or emerging biotechnology company.

This is a full‑time role designed to be primarily onsite at our Cambridge office, typically 4–5 days per week.

Occasional travel to contract manufacturing sites, laboratories, and other locations may be required, as well as occasional after‑hours calls with international vendors.

Judo Bio is committed to fostering an inclusive hiring process and providing equal employment opportunities. All qualified applicants will receive consideration for employment without regard to sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other characteristic protected by federal, state, or local law. Judo Bio is an E-Verify employer.

The pay range below represents the anticipated full‑time base salary range for this position at the time of posting. Individual compensation will be determined based on a number of factors, including relevant experience, skills, education, and other job‑related considerations. In addition to base salary, this position is eligible for bonus and equity.

Judo Bio offers a comprehensive benefits package designed to support the health and well‑being of our employees. Benefits include medical, dental, and vision coverage, life and disability insurance, health savings accounts, and a 401(k). Eligible employees also enjoy a $100 monthly mobility stipend, transportation benefit, unlimited time off, company paid holidays, and a year‑end company‑wide recharge break.

We believe investing in our people strengthens the impact we can make together.