Quality Assurance Manager

Verbatim Pharma; Princeton (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading pharmaceutical company is seeking a QA Manager in Princeton, NJ. In this role, you will own US QA activities and ensure compliance with DSCSA and GDP while collaborating with international teams to support critical clinical research. The ideal candidate will have 5+ years of FDA and EU GDP experience and strong DSCSA compliance expertise.

Qualifications

• 5+ years’ experience in US FDA 21 CFR and EU GDP environment.
• Strong DSCSA knowledge with hands-on compliance expertise.
• Independent and collaborative communicator.

Responsibilities

• Serve as SME and point of contact for DSCSA compliance.
• Manage US licenses and liaise with FDA and external partners.
• Oversee QA for packaging, labelling, storage, and distribution.
• Lead supplier and vendor qualifications, audits, and trainings.
• Handle deviations, complaints, CAPAs, and change controls.
• Support global QA colleagues on GxP activities and SOP updates.

Skills

DSCSA compliance expertise

Quality Assurance management

Collaboration with global teams

Detail-oriented communication

Education

Degree-level education

Job description

Overview

QA Manager – Princeton, NJ, Pharmaceutical Services. You’ll own US QA activities, ensure compliance with DSCSA and GDP, and collaborate with global teams to support clinical trial supply and distribution.

What’s in It for You

• Key responsibility for US QA operations.
• Join a global, growing, client-focused organization.
• Work with international teams supporting critical clinical research.

What You’ll Be Doing

• Serve as SME and point of contact for DSCSA compliance.
• Manage US licenses and liaise with FDA and external partners.
• Oversee QA for packaging, labelling, storage, and distribution.
• Lead supplier and vendor qualifications, audits, and trainings.
• Handle deviations, complaints, CAPAs, and change controls.
• Support global QA colleagues on GxP activities and SOP updates.

What We’re Looking For

• Degree-level education.
• 5+ years’ experience in US FDA 21 CFR and EU GDP environment.
• Strong DSCSA knowledge and hands-on compliance expertise.
• Independent, detail-oriented, and collaborative communicator.