Senior GCP QA Leader - Compliance & Audit Excellence

Shionogi Inc.; Florham Park (NJ); On-site; USD 160,000 - 190,000; Full time

Job summary

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.

Qualifications

• 7+ years of experience in QA, Compliance, or Regulatory roles supporting GCP in clinical development.
• Strong knowledge of ICH, FDA, EMA, MHRA, PMDA and local regulatory requirements.
• Experience planning and managing audits of sites, CROs, vendors, and internal processes.

Responsibilities

• Provide quality oversight of clinical trial conduct to ensure GCP regulatory compliance.
• Serve as QA representative and advisory to the clinical study team(s).
• Evaluate trial documentation and processes for regulatory alignment and quality.
• Develop and manage GCP audit plans and risk-based audits across sites and vendors.
• Lead CAPA investigations and ensure timely closure and effectiveness.

Skills

GCP QA

Regulatory Compliance

Audit Management

CAPA & Investigations

Cross-functional Collaboration

Education

BA/BS in life sciences

Job description

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.