Senior GCP Inspection Lead
vor 3 Wochen
BeiGene is seeking an experienced Associate Director to lead our GCP Inspection Readiness team in EMEA. As a key member of our Quality Assurance team, you will be responsible for ensuring that our clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
Key Responsibilities:- Lead and manage GCP inspection readiness activities, including developing and implementing inspection readiness strategies and managing inspection logistics.
- Collaborate with cross-functional clinical study teams to ensure a unified approach to inspection readiness.
- Manage Inspection Readiness Checklist, develop storyboards, identify and mitigate inspection risks, and facilitate/lead mock and actual inspections.
- Assign inspection requests to appropriate subject matter experts and provide guidance to ensure timely fulfillment.
- Create/revise SOPs and tools for inspection readiness and management.
- Implement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs.
- Demonstrate ability to solve complex problems requiring in-depth evaluation of various factors.
- Fulfill all inspection commitments, respond to inspections, and carry out post-inspection activities, corrective and preventative actions, and resolve any issues for timely closure.
- Manage a central repository of global inspection status and updates.
- Meticulous attention to detail, excellent reviewing skills, and ability to independently manage multiple tasks in a fast-paced environment.
- Support/manage pre-inspection visits at investigative sites.
- Lead and manage lessons learned sessions after inspections, identifying trends and best practices to implement process improvements.
- Proven ability to set strategies for and drive initiatives aimed at improving quality processes.
- Strong leadership skills and ability to mentor others.
- 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.
- 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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