Job Title: Quality Manager
Location: Princeton, New Jersey (On-Site)
Job Summary: We are recruiting for an opportunity supporting clinical quality activities with a strong focus on audit coordination, inspection readiness, and CAPA management. This position plays an important part in helping maintain quality system processes and supporting cross-functional teams across clinical development activities.
Responsibilities:
- Support coordination and execution of the GCP audit program, including investigator site, vendor, and internal process audits.
- Assist with audit preparation meetings, documentation, audit packages, reports, and follow-up actions.
- Maintain quality records, track CAPAs, and support continuous improvement within clinical quality systems.
- Contribute to regulatory inspection readiness activities, meeting coordination, reporting, and quality metrics support.
Required:
- Bachelor’s degree in Life Sciences or a related scientific discipline preferred.
- Minimum 5 years of relevant experience in pharmaceutical, biotechnology, or clinical research environments.
- Exposure to clinical trial operations, quality assurance, monitoring activities, quality systems, CAPA management, or inspection readiness activities.
- Foundational knowledge of Good Clinical Practice (ICH E6), applicable regulations, and clinical development processes.
- Proficiency with Microsoft Office, including Excel, PowerPoint, and Word.
- Familiarity with quality management systems such as TrackWise, Veeva, or ACE is preferred.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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