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Shionogi Inc.

Associate Director, GCP QA

Shionogi Inc. Florham Park, New Jersey, United States · $160K–$190K/yr

Pharmaceutical Manufacturing · 501-1,000 employees

6 d ago
qa Senior (5-10 yrs) Full-time United States
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About the role

The Associate Director provides senior-level quality oversight for clinical development activities to ensure compliance with global regulatory requirements. They manage risk-based audits, oversee vendor quality, and lead inspection readiness efforts to safeguard patient safety and data integrity.

What they look for

GCP Quality Assurance Clinical Development Regulatory Compliance Audit Management CAPA Management Risk-based Auditing Vendor Oversight Regulatory Inspection Readiness Root Cause Analysis Quality Agreements Data Integrity Patient Safety ICH Guidelines FDA Regulations Cross-functional Leadership Quality Systems

Requirements

Candidates must hold a bachelor's degree in life sciences or a related field and possess at least 7 years of progressive experience in GCP Quality Assurance. A strong background in global regulatory guidelines, CAPA management, and audit execution is required.

Benefits

Bonus Long-term incentive Allowances

Full description

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