Associate Director, GCP QA - Clinical Compliance & Audits

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

Job summary

Shionogi Inc. in Florham Park, NJ seeks an Associate Director, GCP QA (Finance) to provide senior-level quality oversight for clinical development and ensure compliance with ICH, FDA, EMA, PMDA, MHRA and other global requirements.

The role serves as QA representative to study teams and leads risk-based audits of sites, CROs, and vendors. The incumbent plans and conducts audits, drives CAPA implementation, supports regulatory inspection readiness, and collaborates with cross-functional partners

Qualifications

• BA/BS in life sciences or related field.
• 7 years of progressive experience in QA/compliance supporting GCP in clinical development.
• Strong working knowledge of global GCP regulations (ICH, FDA, EMA, PMDA, MHRA).
• Experience planning, conducting, and managing audits of sites, CROs, vendors, and internal processes; experience with regulatory inspections.

Responsibilities

• Provide quality oversight of clinical trial conduct to ensure GCP regulatory compliance.
• Serve as QA representative and advisor to assigned study teams.
• Evaluate documentation to ensure alignment with regulatory requirements.
• Interpret and resolve GCP compliance issues for cross-functional teams.
• Develop and execute GCP audit plans using a risk-based approach.
• Manage internal and external audits including investigator sites, CROs, vendors, and labs.
• Follow up audits and close CAPAs timely.
• Support readiness for GCP regulatory inspections and provide inspection support.
• Manage quality investigations and CAPA effectiveness.
• Act as a key quality contact for external vendors and establish Quality Agreements.
• Assess vendor-related risks and implement mitigation strategies.

Education

BA/BS in life sciences

7 years of QA/Regulatory experience

GCP QA knowledge

Audit planning and execution

CAPA management

Tools

CAPA systems

Job description

Shionogi Inc. in Florham Park, NJ seeks an Associate Director, GCP QA (Finance) to provide senior-level quality oversight for clinical development and ensure compliance with ICH, FDA, EMA, PMDA, MHRA and other global requirements.

The role serves as QA representative to study teams and leads risk-based audits of sites, CROs, and vendors. The incumbent plans and conducts audits, drives CAPA implementation, supports regulatory inspection readiness, and collaborates with cross-functional partners