Senior GCP Quality Lead: Audits & Inspections

BeOne Medicines Ltd.; Netherlands; Presencial; EUR 106.000 - 132.000; Jornada completa

Descripción de la vacante

BeOne Medicines Ltd. is seeking an Associate Director, GCP Audits and Inspections, to lead GCP audits and support regulatory inspection readiness. You will provide independent quality oversight across clinical development programs and collaborate with cross-functional teams to mitigate risks and drive improvements.

You will oversee vendor audits, lead inspection readiness activities, and mentor auditors, utilizing Veeva Vault and other quality systems to document and track activities.

Formación

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.
• 8+ years of experience in GCP Quality Assurance, GCP auditing, regulatory inspection support/management, Clinical Operations, or related activities.
• Experience conducting and leading GCP audits (investigator site, vendor, process/system).
• Experience supporting or leading GCP regulatory inspection readiness and Health Authority inspection activities.
• Strong knowledge of ICH GCP, global clinical trial regulations, and RBQM principles.
• Demonstrated leadership, communication, analytical, and problem-solving skills.

Responsabilidades

• Lead risk-based GCP audits including investigator site, vendor, process/system, and internal audits.
• Plan, prepare, conduct, document, and report audits with clear communication of risks.
• Support CGP inspection readiness and Health Authority inspections.
• Provide GCP quality leadership for assigned compounds or programs.
• Oversee vendor audit activities and risk-based quality oversight.
• Mentor auditors and collaborate with Clinical Operations and Regulatory Affairs.

Conocimientos

GCP auditing

Regulatory inspection

Leadership

Cross-functional collaboration

Project management

Communication

Stakeholder management

Educación

Bachelor’s degree in Life Sciences/Pharmacy/related field

Master’s degree preferred

Herramientas

Veeva Vault

Descripción del empleo

BeOne Medicines Ltd. is seeking an Associate Director, GCP Audits and Inspections, to lead GCP audits and support regulatory inspection readiness. You will provide independent quality oversight across clinical development programs and collaborate with cross-functional teams to mitigate risks and drive improvements.

You will oversee vendor audits, lead inspection readiness activities, and mentor auditors, utilizing Veeva Vault and other quality systems to document and track activities.