Senior GCP Audits & Inspections Lead

BeiGene; Basel; On-site; CHF 149,000 - 186,000; Full time

Job summary

BeOne is seeking an Associate Director, GCP Audits and Inspections within R&D Quality & GxP Auditing to lead and execute GCP audits, support regulatory inspection readiness, and provide quality oversight across clinical development programs.

The role collaborates with cross-functional stakeholders and utilizes Veeva Vault to plan, document, and track audit activities, with travel to international sites as needed.

Qualifications

• Bachelor's degree (or higher) in Life Sciences, Pharmacy, Business, or related field.
• Master's degree preferred.
• Experience in GCP QA, auditing, or regulatory inspection support.

Responsibilities

• Lead and conduct risk-based GCP audits, including investigator site, vendor, process/system, and internal audits.
• Plan, prepare, conduct, document, and report audits with clear risk observations.
• Evaluate audit findings responses and CAPAs, ensuring follow-up.
• Develop and execute GCP audit strategies based on risks and regulations.
• Identify audit trends and opportunities for quality improvement.
• Lead or co-lead GCP inspection readiness activities and support inspections.
• Prepare inspection risk assessments, storyboards, mock inspections, and readiness assessments.
• Coordinate inspection requests and support SMEs in responses.
• Provide GCP quality leadership for assigned compounds/programs.
• Escalate significant GCP risks and provide independent quality perspectives.
• Oversee vendor audits and quality assessments with cross-functional partners.
• Document audit and quality oversight activities in Veeva Vault and other systems.

Skills

GCP Quality Assurance

GCP Auditing

Regulatory Inspection Support

Clinical Operations

Leadership

Education

Bachelor’s degree in Life Sciences, Pharmacy, Business, or related field

Master’s degree preferred

Tools

Veeva Vault

CTMS

eTMF

Job description

BeOne is seeking an Associate Director, GCP Audits and Inspections within R&D Quality & GxP Auditing to lead and execute GCP audits, support regulatory inspection readiness, and provide quality oversight across clinical development programs.

The role collaborates with cross-functional stakeholders and utilizes Veeva Vault to plan, document, and track audit activities, with travel to international sites as needed.