Senior GCP Inspection Lead
vor 2 Monaten
BeiGene is seeking a highly skilled and experienced Senior GCP Inspection Lead to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the company's compliance with regulatory requirements and guidelines.
Key Responsibilities- Lead and manage GCP inspection readiness for cross-functional clinical study teams
- Collaborate with clinical operations, pharmacovigilance, and regulatory affairs teams to ensure a unified approach to inspection readiness
- Develop and implement inspection readiness checklists, storyboards, and risk mitigation strategies
- Assign inspection requests to subject matter experts and provide guidance for timely fulfillment
- Create and revise SOPs and tools for inspection readiness and management
- Implement and maintain key QA systems, including investigations, SQEs, deviations, and CAPAs
- Manage a central repository of global inspection status and updates
- BA/BS degree required
- Expert knowledge of FDA, EU, and ICH GCP guidelines
- Minimum of 7 years of experience in GCP-related Quality Assurance
- High level of understanding of international GCP requirements and standards
- Excellent English language skills and additional language skills depending on locations and need
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment
Flexible to travel, including international. May require up to 35% travel, sometimes with short notice time.
BeiGene Global CompetenciesWhen we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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