Job Description

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.

General Description:

The Manager, Distribution & Regional Quality, Europe Quality is responsible for overseeing Good Manufacturing Practices (GMP) as well as Good Distribution Practice (GDP) operations related to the commercial products including trading in foreign countries.

This position ensures compliance with EU GMP and GDP regulations on transportation, wholesale and distribution as well as adherence to EU regulations and to French regulation applicable to exploitant facility (French health code, local french GMP/GDP; and HAS (Haute Autorité de Santé) certification for promotional activities) as well as BeOne's internal quality processes and procedures.

BeOne operates several affiliates in Europe and holds different GxP licenses in these affiliates. The job incumbent will execute the assigned activities on behalf of the below listed affiliates based on the license utilized.

Affiliates in scope: BeOne Medicines France Sarl, BeOne Medicines I GmbH, BeOne Medicines I GmbH, Dutch Branch, BeOne Medicines UK, Ltd and BeOne Medicines Germany GmbH

For activities performed for Switzerland under BeOne Medicines I GmbH the allowed delegations per VV-QDOC-10970 CH – Deputization and Delegation of RP Tasks within BeiGene Switzerland GmbH apply.

Essential Functions of the job:

• Batch Review and EU QP batch certification support
• Ownes and manages assigned SOPs/WIs
• Prepare, manage and maintain documentation and reports required to support and improve the execution of Distribution Quality activities
• Batch review and release preparation for commercial APIs, primary packed products and finished products manufactured by contract manufacturers on behalf of BeOne.
• Conduct GDP releases post QP batch certification
• Perform customer and wholesaler approval
• Deviation Management (incl. Temperature Excursions, deviations to exploitant specific processes), CAPA and Change Control Management
• Complaint Management (distribution complaints and market complaints)
• Support launch of new products and Early Access Programs in a country
• Ensure Inspection readiness within area of responsibility
• Support Health Authority Inspections and Audits as needed.
• Support and work with in-country wholesalers and distributors
• Support Quality Oversight of GDP operations and compliance (including exploitant operations)
• Support the implementation of Quality requirements within the Distribution/Exploitant scope
• Support the customer product returns process and evaluation of the product for use
• Support the establishment of Quality Agreements with local distributors / wholesalers/ vendors
• Assist with preparation and provision of Key Performance Indicator metrics
• This is a hands-on position

Education Required:

• Min 5+ years of relevant experience in GMP/GDP Quality in pharmaceutical industry with a Bachelors degree
• Solid foundation in QA and understanding of product manufacturing and distribution quality requirements.
• Solid experience in Exploitant regulation and related Quality System, including experience on the implementation of the REPs charter (HAS promotional information certification)

Computer Skills:

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint), Veeva, SAP
• Ability to work on a computer for extended periods of time

Core Knowledge and Skill Requirements

• EU GMP experience
• EU/FR GDP experience
• FR exploitant WDA/licence expérience
• FR Charter for promotional activities experience
• Fluent in French
• Fluent in English

Other Qualifications:

• Very good interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.

Travel:

• Max 10 %

Salary Range France: 60,200.00 EUR - 75,300.00 EUR

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.