Senior GCP QA Leader - Compliance & Audit Excellence
shionogiFlorham Park (NJ)
Senior GCP QA Leader - Compliance & Audit Excellence
Posted today
shionogiFlorham Park (NJ)
SENIORITY
Manager
About the role
Shionogi Inc. is seeking an Associate Director, GCP Quality Assurance to provide senior-level quality oversight for clinical development activities, ensuring compliance with ICH, FDA, EMA, PMDA, MHRA and other global requirements.
You will lead risk-based audits of investigator sites, CROs, vendors, and internal processes, drive CAPA resolution, and support regulatory inspection readiness.
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.