Senior GCP Audits & Inspections Lead

BeOne Medicines Ltd.; Basel; On-site; CHF 149,000 - 186,000; Full time

Job summary

BeOne Medicines Ltd. in Basel, Switzerland, is seeking an Associate Director, GCP Audits and Inspections, to lead and oversee GCP audits, inspection readiness, and quality oversight across clinical development programs.

The role utilizes Veeva Vault and other systems to support audit planning, documentation, and CAPA closure. You will partner with cross-functional study teams to develop risk-based inspection readiness strategies, support Health Authority inspections, and provide independent

Qualifications

• Bachelor’s degree in Life Sciences or related field; Master’s preferred.
• 8+ years in GCP QA, audits, or regulatory inspection support in pharma/biotech.
• Experience leading GCP audits (investigator site, vendor, internal).
• Experience supporting GCP regulatory inspection readiness and health authority activities.

Responsibilities

• Lead and conduct risk-based GCP audits across sites, vendors, and processes.
• Plan, document, and report audits with identified GCP risks.
• Coordinate inspection readiness activities and respond to requests during inspections.
• Provide GCP quality leadership for assigned compounds or programs.
• Oversee vendor audits and quality oversight with cross-functional teams.

Skills

GCP auditing

Quality assurance

Regulatory compliance

Leadership

Risk assessment

Vendor management

Education

Bachelor’s degree in Life Sciences

Master’s degree preferred

Tools

Veeva Vault

CTMS

eTMF

MS Office

Job description

BeOne Medicines Ltd. in Basel, Switzerland, is seeking an Associate Director, GCP Audits and Inspections, to lead and oversee GCP audits, inspection readiness, and quality oversight across clinical development programs.

The role utilizes Veeva Vault and other systems to support audit planning, documentation, and CAPA closure. You will partner with cross-functional study teams to develop risk-based inspection readiness strategies, support Health Authority inspections, and provide independent