Senior GVP/GCP QA Leader – Compliance & Inspections

Shionogi Inc. (U.S.); Florham Park (NJ); Hybride; USD 135 000 - 165 000; Plein temps

Résumé du poste

Shionogi Inc. (U.S.) is seeking a GVP/GCP QA lead to support and maintain a global PV quality program, collaborating with Global QA teams to ensure regulatory compliance with FDA, EMA, MHRA, PMDA and ICH, including PV systems and PSMF.

The role develops, implements, and maintains QMS, leads audit strategies, supports regulatory inspections, travels up to 15%, and works in a hybrid model at the Florham Park, NJ headquarters.

Qualifications

• BA/BS in life sciences or related field.
• 6+ years in a GVP/GCP QA/quality/compliance role or regulatory inspectorate role.
• Working knowledge of GVP/GCP regulations (ICH, FDA, EMA, MHRA, PMDA).

Responsabilités

• Develop, implement, and maintain GVP/GCP QMS.
• Prepare for regulatory inspections and develop/audit strategies.
• Ensure ongoing compliance with GVP/GCP regulatory requirements and maintain PSMF.
• Manage CAPAs and effectiveness checks.

Connaissances

Attention to detail

Team player

Agile

Communication skills

Critical thinking

Problem solving

Formation

Bachelor's degree in life sciences

Description du poste

Shionogi Inc. (U.S.) is seeking a GVP/GCP QA lead to support and maintain a global PV quality program, collaborating with Global QA teams to ensure regulatory compliance with FDA, EMA, MHRA, PMDA and ICH, including PV systems and PSMF.

The role develops, implements, and maintains QMS, leads audit strategies, supports regulatory inspections, travels up to 15%, and works in a hybrid model at the Florham Park, NJ headquarters.