Senior Specialist, Commercial Quality – Europe

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 for commercial finished products manufactured by internal sites or contract manufacturers on behalf of BeOne Prepare, manage and maintain documentation and reports required to support and improve the execution of Distribution Quality activities Conduct GDP releases post QP batch certification Perform customer and wholesaler approval Minor/major deviation Management (incl. Temperature Excursion), CAPA and Change Control Management support Complaint Management (distribution complaints and market complaints) 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 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 of Quality Agreements with local distributors / wholesalers Assist with preparation and provision of Key Performance Indicator metrics This is a hands-on position Supervisory Responsibilities: None Education Required: Min 3+ 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 German is a plus Other Qualifications: Very good interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail. Travel: Max 10 % Salary Range Switzerland: 95,200.00 CHF - 119,000.00 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.