Senior GCP Audits & Inspection Leader

BeiGene, Ltd.; Schweiz; On-site; CHF 149,000 - 186,000; Full time

Job summary

BeiGene, Ltd. is seeking an Associate Director, Good Clinical Practice (GCP) Audits and Inspections to lead GCP audits, support regulatory inspection readiness, and provide quality oversight across clinical development programs.

The role partners with cross-functional teams to ensure compliance with ICH GCP and global regulations. You will oversee vendor audits, manage inspection readiness activities, mentor auditors, and drive continuous improvement using Veeva Vault and related systems.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Business, or related field (Master’s preferred).
• Minimum 8 years of relevant GCP QA, auditing, or regulatory inspection experience.

Responsibilities

• Lead and conduct GCP audits (investigator site, vendor, process/system, internal).
• Plan, document, and report audits with clear risk and observations.
• Support health authority inspections and inspection readiness activities.
• Provide GCP quality leadership for assigned compounds/programs.
• Oversee vendor audits and ongoing quality oversight.

Skills

GCP Quality Assurance

Audit leadership

Regulatory inspection support

Cross-functional collaboration

Mentorship

Education

Bachelor's degree in Life Sciences/Pharmacy/Business or related field

Master's degree preferred

Tools

Veeva Vault

eTMF

CTMS

Job description

BeiGene, Ltd. is seeking an Associate Director, Good Clinical Practice (GCP) Audits and Inspections to lead GCP audits, support regulatory inspection readiness, and provide quality oversight across clinical development programs.

The role partners with cross-functional teams to ensure compliance with ICH GCP and global regulations. You will oversee vendor audits, manage inspection readiness activities, mentor auditors, and drive continuous improvement using Veeva Vault and related systems.