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Manager, Distribution & Regional Quality, Europe

BeiGene -
Basel, BS

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%
CHF 109’500 - CHF 136’900 pro Jahr
vor 11 Stunden

Qualifikationen

Microsoft Powerpoint
Microsoft Excel
Microsoft Outlook
Schreibfähigkeiten
Englisch
Microsoft Office
Bachelor
PC-Kenntnisse
Deutsch
Niederländisch

Vollständige Stellenbeschreibung

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. The role ensures adherence to EU regulations, 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 I GmbH, BeOne Medicines I GmbH, Dutch Branch, BeOne Medicines France Sarl, 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 need to be considered.

Essential Functions of the job:

Trade authorization of finished products manufactured by
- contract manufacturers on behalf of BeOne
- cooperation partners of BeOne
- BeOne
Batch Review and EU QP batch certification preparation: Batch review and release preparation for commercial APIs, primary packed products and finished products manufactured by BeOne or contract manufacturers on behalf of BeOne.
Perform customer and wholesaler approval
Deviation (incl. Temperature Excursion), CAPA and Change Control Management
Complaint Management (distribution complaints and market complaints)
Prepare, manage and maintain documentation and reports required to support and improve the execution of Regional Quality activities
Conduct GDP releases post QP batch certification
Ensure Inspection readiness within area of responsibility
Support Health Authority Inspections and Audits as needed.
Support launch of new products in a country
Quality representative in SAP Project for local affiliate
Support and work with in-country wholesalers and distributors/3PLs
Support Quality Oversight of GDP operations and compliance
Support the implementation of Quality requirements within the Distribution scope
Support the customer product returns process and evaluation of the product for use
Support the establishment/update of Quality Agreements with local 3PLs / distributors / wholesalers
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 Distribution Quality in pharmaceutical industry with a Bachelors degree.
Solid foundation in QA and understanding of product distribution quality requirements.

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 GDP experience
Fluent in English
Fluent in German is a plus

Other Qualifications:

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

Travel:

Max 10 %

Salary Range Switzerland: 109,500.00 CHF - 136,900.00 CHF

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.

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