Global GVP/GCP QA Manager – PV Compliance

Shionogi Inc.; Florham Park (NJ); Hybrid; USD 135,000 - 165,000; Full time

Job summary

Shionogi Inc. seeks a GVP/GCP QA leader to support and maintain a robust quality program across PV and regulatory functions. You will collaborate with Global QA teams to oversee PV compliance, audits, and regulatory inspections, ensuring alignment with FDA/EMA/MHRA/PMDA guidelines.

The role requires coordination of QMS, PSMF maintenance, CAPA processes, and cross-functional teamwork. Travel up to 15% domestically/internationally, with hybrid office presence in Florham Park, NJ.

Qualifications

• BA/BS in life sciences, a scientific, technical discipline, or a related field.
• Minimum of 6 years of experience in a GVP/GCP QA/quality/compliance role or regulatory inspectorate role supporting PV and/or clinical study teams.
• Working knowledge of GVP/GCP regulations and guidelines, including ICH, FDA, EMA, MHRA and PMDA requirements.

Responsibilities

• Engage in the development, implementation, and maintenance of the GVP and GCP Quality Management System (QMS), ensuring compliance with worldwide and local PV regulations.
• Actively engage in preparedness for regulatory inspections, e.g., FDA PADE inspection. Collaborate with the Global QA teams in the development and execution of audit strategies, manage, oversee or conduct audits.
• Ensure ongoing compliance with relevant GVP and GCP global and local regulatory requirements and guidelines, including management and support in maintenance of Pharmacovigilance System Master Files (PSMF).
• Manage compliance with risk assessments, facilitate root cause analysis, and ensure the implementation and effectiveness of Corrective and Preventive Actions (CAPAs) and effectiveness checks.
• Act as a primary GVP Quality contact of all GVP related matters and GCP Quality contact as assigned, collaborating with cross-functional teams and internal departments.
• Drive the continuous improvement of GVP and GCP quality systems and procedures.
• Other duties as assigned.

Skills

Attention to detail

Team player

Communication skills

Critical thinking

Problem-solving

Project management

Leadership

Education

BA/BS in life sciences

Job description

Shionogi Inc. seeks a GVP/GCP QA leader to support and maintain a robust quality program across PV and regulatory functions. You will collaborate with Global QA teams to oversee PV compliance, audits, and regulatory inspections, ensuring alignment with FDA/EMA/MHRA/PMDA guidelines.

The role requires coordination of QMS, PSMF maintenance, CAPA processes, and cross-functional teamwork. Travel up to 15% domestically/internationally, with hybrid office presence in Florham Park, NJ.