Introduction

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.

Your tasks

General Description:

The incumbent will report to the Director, Distribution & Regional Quality, Europe Commercial Quality Head.

The Manager, Distribution & Regional Quality, Europe Quality is responsible for overseeing Good Distribution Practice (GDP) Operations related to the commercial products. This position ensures compliance with EU GDP regulations on transportation, wholesale and distribution. The role ensures adherence to EU regulations, as well as BeOnes internal quality processes and procedures.

Essential Functions of the job:

• Support Quality Oversight of GDP operations and compliance
• Support the implementation of Quality requirements within the Distribution scope
• Prepare, manage and maintain documentation and reports required to support and improve the execution of Distribution Quality activities
• Perform customer and wholesaler approval
• Quality representative in SAP Project for local affiliate
• Support launch of new products in the country
• Ensure Inspection readiness with EU GDP RP and Quality Europe within area of responsibility
• Support Health Authority Inspections and Audits as needed.
• Support and work with in-country wholesalers and distributors
• Support the customer product returns process and evaluation of the product for use
• Support the establishment of Quality Agreements with local distributors / wholesalers
• Deviation (incl. Temperature Excursion), CAPA and Change Control Management
• Complaint Management (distribution complaints and market complaints)
• Batch Review and EU QP batch certification support
• Qualify as EU GDP RP (Deputy) in Germany based on §52a AMG
• Assist with preparation and provision of Key Performance Indicator metrics

Your profile

Computer Skills:

• SAP
• Veeva
• Microsoft Office

Qualifications:

• Min 5+ years of relevant experience in Distribution Quality in pharmaceutical industry with a Bachelors degree
• Solid foundation in QA and understanding of product distribution quality requirements.
• Strong EU GDP experience
• Qualify as EU GDP RP (Deputy)
• Experience according to German GDP regulations
• EU GMP experience
• Fluent in German and English
• Very good interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.

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 offer

Travel:

Max 10 %

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.