- Supervise and manage activities related to inspection readiness, leading inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
- Collaborate with cross-functional clinical study teams to ensure a unified approach to inspection readiness strategy.
- Manage Inspection Readiness Checklist, development of storyboards, identify and mitigate inspection risks, and facilitate/lead mock and actual inspections.
- During inspections, assign inspection requests to appropriate subject matter experts (SMEs) and provide guidance to ensure timely fulfillment.
- Create/revise appropriate 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.
- Thorough understanding of international regulations applicable to the conduct of clinical trial operations on a global scale.
- 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, e.g., /. Spanish for LATAM, German, French, etc., for Europe)
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment.
- Quality Assurance
- Clinical Operations
- Pharmacovigilance
- Clinical Business Operations
- Biometrics
- Medical Monitors
- Regulatory Affairs
- Interacts with all levels of BeiGene
- Flexible to travel, including international.
- May require up to 35% travel, sometimes with short notice time.
- 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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Associate Director, Global GCP Inspection Excellence – Europe - Basel, Schweiz - BeiGene
Beschreibung
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
Reporting to the Director, Global GCP Inspection Excellence, the inspection lead will be primarily responsible for GCP Health Authority inspection readiness for cross-functional clinical study teams, managing inspection logistics and process improvements to ensure research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.
Tasks & Requirements:
Qualifications:
Significant Contacts
Travel:
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.
