Manager/Senior Manager, Distribution and Regional Quality, Japan

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

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.

Job Description:

General Description:
Executing the compliant and uninterrupted supply of BeOne products in accordance with BeOne’s quality management system and expectations from Japanese health authorities during new product commercialization and commercial product supply under GQP Ordinance.

Essential Functions of the job:
• Ensure that local activities of the manufacturing site comply with relevant regulations such as GQP and GDP guidance, including warehouse/ testing laboratory
• Execute in country disposition / release activities for Japan under GQP Ordinance.as a part of Marketing Authorization Holder
• Create and update and maintain local quality procedures (GQP SOPs)
• Collaborate with the colleagues in Quality to manage external audits, complaints, deviations, recalls, counterfeits and product tampering according to GQP SOPs and the BeOne quality system procedures
• Engage in complaint management processes consistent with Japan's market expectations and the requirements of HA.
This includes: - Developing and delivering commercial and sales rep training to ensure facilitation of collection of information - represent Japan on the global complaint network team to ensure that the global process is fit for purpose for Japan market expectations and the HA. - Analyze complaint data trends and propose appropriate CAPA measures.
- Acting as one of the contacts for vendors for complaint management within Japan
• Manage and/or evaluate relevant change control relating to Japan/relevant countries product (new product introductions /lifecycle changes/distribution readiness)
• Assist the recall team as a coordinator for local recalls and mock recall
• Regularly report on Japan's quality matters to the Japan Quality Head and Participate in regional management reviews and provide necessary information as required.

Qualification and oversight of 3rd party providers:
• Conduct audits and evaluations of third-party providers, ensuring they meet BeOne’s quality standards.
• Maintain quality agreements and monitor their compliance with service level expectations.
• Participate in KPI and business reviews.
• Participate / respond to corporate audits and Health authority inspection for local manufacturer/ distribution center/ testing laboratory, as needed.
• Evaluating management of temperature sensitive products including lane qualifications, shipper qualification, temperature excursion assessments, transport validation

Support for new products launch:
• Participate in the product introduction processes for new product as quality expertise, ensuring a robust quality assurance system is established Provide training and support necessary for new product launches, ensuring adherence to GQP requirements and readiness for the market.
• Support the maintenance of GQP license, as well as Wholesaler license.

• Ensure the quality of Investigational Medical Product

Qualification Required:

Education Required:
Bachelor degree or Science degree, in a related scientific discipline

Supervisory Responsibilities:
• Work collaboratively with the colleagues in Quality and report to Japan Quality Head, to execute measures ensuring quality and a better workplace.

Computer Skills: Microsoft office suite, Zoom (or equivalent), Veeva, QMS software systems.

Other Qualifications: As required

Travel: As required

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

BeOne 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

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.