Associate Manager/Manager, Distribution and Regional Quality, South Korea

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:

About the Position

The role is responsible for ensuring compliant and uninterrupted supply of BeOne Medicinal products for the import / export products to/from collaboration partners in accordance with BeOnes quality management system and Korea/other JAPAC regulatory authority expectations.

Main Responsibilities

• Support and act as a back up person for the SK Country Quality Head, as licensed pharmacist and a licensed holder for the local affiliate in SK

• Ensure local activities comply GIP (Good Import Practice) and relevant GDPs and Quality Management System including warehouse/lab management

• In country disposition / release activities for Korea and other JAPAC countries as required.

• Develop, update and maintain local quality procedures and input into global policy, SOP, and guideline development

• Manage the tech transfer and other activities as needed for local Korean testing laboratory

• Manage external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the BeOne Medicines quality system procedures

• Act as the JAPAC SME for relevant quality systems based on regional need and expertise

• Oversight of 3rd party providers – support audits, quality agreements, monitoring activity, participate in KPI and business reviews

• Participate / respond to corporate audits and self-assessments for responsible countries

• Management of temperature sensitive products including lane qualifications, shipper qualification, temperature excursion assessments, transport validation

• Quality subject matter expert for MFDS or other HA inspection and communication, as required

• Support for new products launch

• Manage and/or approve relevant change control relating to Korea/relevant countries product (new product introductions /lifecycle changes/distribution readiness)

• GxP training content development and delivery for Korea and responsible countries employees

• Recalls including mock recall and local recall site coordinator for the Global VP Quality and recall management team

• Point of contact/SME from Quality for Korea and responsible countries

• Contribute and participate in the regional/global management review

• Participate in the Annual Product Review

• Quality input into state based, commercial tenders and/or hospital formulary as required

• Provide Support with Health Authority and Business Partner audits

Qualification Required:

Education Required:

Korea Pharmacist Licence is required.

Bachelor’s degree of Science in Pharmacy, in a related scientific discipline

Supervisory Responsibilities: 

• Individual contributor

Computer Skills:   

• Proficiency with Microsoft office including teams, SharePoint.  Veeva, SAP

Other Qualifications:    

• Current Registered Pharmacist in Korea, Korean and English language skills

• Bachelor’s degree in chemistry/biology or related scientific discipline

• (Associate Manager) 5~7 years’ experience in quality management of commercial drug products in a pharmaceutical company

• (Manager) 8+ years’ experience in quality management of commercial drug products in a pharmaceutical company

• Cold chain distribution quality management highly regarded

• Experience in complaint and temperature excursion management highly regarded

• Experience in oversight the drug wholesaler and distributors highly regarded

• Strong Communication & Interpersonal Skills required

Travel: 

• As required (current passport required) – some domestic

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme

• Company shares (generous welcome grant!)

• 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 in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year 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.