Overview
BeOne 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.
At BeOne Medicines, we are dedicated to advancing the quality of global clinical trials through outstanding regulatory compliance and excellence. As the Inspection Lead reporting to the R&D Quality, Sr. Director of Global GCP Inspection Management, you'll 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.
Key Responsibilities
* Communicates with Clarity: Supervise and guide inspection readiness activities, spearheading inspections by health authorities such as the FDA, EMA, and others. Assign inspection requests to subject matter experts and provide real-time guidance to ensure seamless inspection processes.
* Fosters Teamwork: Work alongside cross-functional clinical study teams to develop and implement a cohesive inspection readiness strategy.
* Analytical Thinking/Data Analysis: Manage and optimize the Inspection Readiness Checklist, develop engaging storyboards, and lead mock inspections to identify and mitigate risks effectively.
* Demonstrates Initiative: Create and refine SOPs and tools that enhance our inspection readiness and management capabilities.
* Operational Excellence: Implement and uphold key QA systems including investigations, Significant Quality Events (SQEs), and CAPAs to ensure compliance and excellence.
* Solve Complex Challenges: Demonstrate exceptional problem-solving abilities by conducting thorough evaluations in high-pressure situations.
* Results Oriented: Manage all aspects of inspection commitments and engage in post-inspection processes to ensure timely resolutions.
* Continuous Learning: Organize lessons learned sessions after inspections, identifying trends and best practices that can elevate our quality processes.
* Provides and Solicits Honest and Actionable Feedback: Use your strong leadership skills to mentor your colleagues, fostering a culture of continuous improvement.
Qualifications
* Bachelor’s degree is required; advanced degrees preferred.
* Prior experience leading independently inspections from Health Authorities (MHRA, EMA, etc.).
* In-depth knowledge of FDA, EU, and ICH GCP guidelines.
* A minimum of 7 years of experience in GCP-related Quality Assurance within pharmaceutical, biotechnology, or healthcare industries.
* High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries.
* Fluency in English; additional language skills (e.g., Spanish, German, French) are a plus.
* Superior verbal and written communication skills.
* Ability to thrive in a dynamic, collaborative environment.
Significant Contacts
You will interact with key stakeholders across various departments, including Quality Assurance, Clinical Operations, Pharmacovigilance, Clinical Business Operation, Regulatory Affairs, and more, playing a pivotal role in our global operations.
Travel Requirements
This position may require flexible international travel, with a commitment of up to 35% travel, occasionally with short notice.
Ready to Make Your Mark?
If you are passionate about quality assurance and are eager to drive change in the clinical research landscape, we invite you to apply and join us on this exciting journey at BeOne Medicines. Together, we can make a difference in the lives of patients around the world!
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, 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
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
#J-18808-Ljbffr