Senior GCP Audits & Inspections Leader

BeOne Medicines Ltd.; Paris; On-site; EUR 120,000 - 170,000; Full time

Job summary

BeOne Medicines Ltd. is seeking an Associate Director, GCP Audits and Inspections, to lead and execute GCP audits, support regulatory inspection readiness, and provide quality oversight across clinical programs.

You will collaborate with cross-functional teams and utilize Veeva Vault to manage audit and inspection activities. The role requires extensive GCP knowledge, leadership, and the ability to mitigate complex compliance risks while driving continuous improvement in quality systems and

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Business, or related field (Master’s preferred).
• Minimum 8 years of relevant experience in GCP Quality Assurance, GCP auditing, regulatory inspection support/management, Clinical Operations, or related activities.
• Experience conducting and leading GCP audits, including investigator site, vendor, process/system, and/or internal audits.
• Experience supporting or leading GCP regulatory inspection readiness and Health Authority inspection activities.

Responsibilities

• Lead and conduct risk-based GCP audits, including investigator site and vendor audits, in accordance with audit plans.
• Plan, prepare, conduct, document, and report audits with clear communication of risks and observations.
• Evaluate responses to audit findings and CAPAs and ensure follow-up.
• Develop and execute GCP audit strategies based on regulatory and quality risks.
• Lead and co-lead inspection readiness activities and support Health Authority inspections.
• Provide QA leadership for assigned compounds or programs and collaborate with cross-functional teams.

Skills

GCP quality assurance

GCP auditing

Regulatory inspection support

Leadership

Communication

Education

Bachelor’s degree in Life Sciences

Master’s degree preferred

Tools

Veeva Vault

eTMF

CTMS

Job description

BeOne Medicines Ltd. is seeking an Associate Director, GCP Audits and Inspections, to lead and execute GCP audits, support regulatory inspection readiness, and provide quality oversight across clinical programs.

You will collaborate with cross-functional teams and utilize Veeva Vault to manage audit and inspection activities. The role requires extensive GCP knowledge, leadership, and the ability to mitigate complex compliance risks while driving continuous improvement in quality systems and