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.