BeOne Medicines

Senior Manager, GCP Auditor

BeOne Medicines

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $130,600 - $175,600 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Senior Auditor role overseeing and conducting GCP audits to ensure compliance with GCP regulations and industry standards, in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.\n
  • The position requires extensive knowledge of ICH GCP and applicable global & local regulations and guidance for clinical development.\n
  • Responsible for audit planning, execution (on-site or remote audits), reporting, CAPA, and coordination with stakeholders.\n
  • Supports GCP, GVP & GLP authority inspections (FDA, EMA, PMDA, TGA, CFDI, etc.) and contributes to preparation and hosting.\n
  • Travel up to 35% internationally; remote work options.\n
  • BeOne is a global oncology company focusing on developing affordable cancer treatments; over 11,000 employees.\n
  • Salary range provided: $130,600 - $175,600 per year.

Requirements

  • BA/BS degree required; advanced degree preferred.\n
  • GCP Quality Assurance auditor’s registration/certification preferred.\n
  • Minimum of 7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry.\n
  • Minimum 3 years as GCP auditors (external and internal audits) and relevant clinical trial experience.\n
  • Minimum 3 years of direct involvement to support or participation in GCP authority inspections.\n
  • High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries.\n
  • Excellent English language skills, and additional language depending on locations and need, e.g., /. Spanish for LATAM, German, French, etc., for Europe)\n
  • Excellent verbal and written communication skills\n
  • Ability to effectively collaborate in a dynamic environment.\n
  • Interacts with all levels of BeiGene.\n
  • Travel: Flexible to travel, including international. May require up to 35% travel, sometimes with short notice time. Audit travel mostly overnight for on-site audits is required - anticipating min 2 audits/month.