GCP Inspection Lead EMEA Position
vor 3 Wochen
BeiGene is seeking a highly motivated and experienced professional to lead our GCP inspection readiness efforts in EMEA. As the GCP Inspection Lead EMEA, you will be responsible for ensuring that our clinical study teams are inspection-ready and that we are in compliance with all applicable regulatory requirements.
Key Responsibilities:
- Develop and implement a comprehensive inspection readiness strategy for EMEA
- Collaborate with cross-functional teams to ensure a unified approach to inspection readiness
- Manage inspection logistics and process improvements to ensure research and development activities are conducted in accordance with applicable regulatory requirements
- Supervise and manage activities related to inspection readiness, leading inspections conducted by regulatory health authorities
- Develop and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs
Requirements:
- BA/BS degree required
- Expert knowledge of relevant FDA, EU, ICH GCP guidelines
- Minimum of 7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry
- High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries
- Excellent English language skills, and additional language depending on locations and need
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment
Travel:
- Flexible to travel, including international
- May require up to 35% travel, sometimes with short notice time
BeiGene Global Competencies
When 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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