Senior Manager, GCP QA

Shionogi Inc. (U.S.)

Senior Manager, GCP QA providing quality oversight for clinical studies and vendor programs. Collaborating with teams to assess and mitigate risks associated with vendors.

Posted 6/18/2026full-timeFlorham Park • New Jersey • 🇺🇸 United StatesSenior💰 $135,000 - $165,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors
Ensure clinical trials adhere to GCP principles, producing high-quality and reliable data
Evaluate clinical trial documentation, processes, and study plans to ensure alignment with Shionogi’s expectations and regulatory requirements
Collaborate with clinical study teams to provide vendor quality oversight, identify risks, and propose remediation actions
Conduct CRO or vendor audits or assessments
Support GCP regulatory inspections and manage assigned CAPAs identified during inspections

Requirements

What you’ll need

BA/BS in life sciences, a scientific, technical discipline, or a related field
Minimum of 5 years of experience in a GCP QA/quality/compliance role supporting clinical study teams
Working knowledge of GCP regulations and guidelines, including ICH, FDA, EMA, and PMDA requirements
Experience in performing GCP-related audits
Strong attention to detail, team player, excellent communication skills, strong critical thinking skills, effective problem-solving abilities
Experience with various types of clinical trials and familiarity with additional regulatory environments
Must live a commutable distance to Florham Park, NJ.

Benefits

Comp & perks

Health insurance
401(k) matching
Paid time off
Professional development opportunities
Wellness programs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCPclinical trial documentationGCP-related auditsregulatory complianceCAPA managementrisk identificationremediation actionsclinical study oversightdata quality assuranceICH guidelines

Soft Skills

attention to detailteam playercommunication skillscritical thinkingproblem-solving