Manager IMP Quality Europe

General Description: 

The incumbent will report to the DIRECTOR, IMP QUALITY, EUROPE HEAD, and will be responsible for supporting activities relating to BeiGene’s external GxP operations in Europe as well as internal BeiGene GxP processes, ensuring procedures and systems are in place to support BeiGene’s investigational medicinal product quality endeavors. 

The position can be based in Switzerland or Germany and has functional assignment to the Head IMP Quality Europe. 

Essential Functions of the job:  

• Provide Quality oversight of internal and external GxP operations, e.g. Drive, lead and troubleshoot quality investigations at internal and external partners to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions (e.g. product temperature excursions). 

• Collaborate with BeiGene's Manufacturing, Supply Chain, Clinical Operations, and Regulatory CMC project teams. 

• Batch record review and batch disposition of finished clinical products manufactured by toll manufacturers on behalf of BeiGene. 

• Take ownership of issues and collaborate with Supply Chain, Clinical Operations, Regulatory Affairs, etc., to drive issues to full resolution for global and EU stakeholders.  

• Monitor and resolve Temperature Excursions as well as other potential issues like Deviations and Complaints. 

• Quality Subject Matter Expert for Deviation, Change Control. 

• Understand and troubleshoot quality and operational processes and practice anomalies to provide compliant and practical solutions to meet global and EU Quality needs meeting a continuous improvement plan between CMOs, partners, and BeiGene. 

• Provide audit/inspection support and support to regulatory filings, as needed. 

• Work cross-functionally to support the development and update of policies and procedures. 

• Close collaboration with EU Qualified Persons to ensure compliance with legislative requirements as provided by Directive 2001/83/EC and Directive 2001/82/EC and MRA. 

• Provide regular updates to management on assigned project progress and escalate challenges as needed. 

• Involvement in the development of training materials and/or programs regarding all aspects of producing quality products. 

• Monitor performance metrics. 

• Other duties as assigned. 

• This is a hands-on position. 

• A plus: experience with Medical Devices and therefore EU MDR (2017/745), FDA 21CFR Part 820) 

• Min 3-6 years pharmaceutical or biotechnology industry experience. 

• GMP/GDP experience in a quality and manufacturing function, preferred in drug development area. 

• Knowledge of global and local GCP regulations. 

• Experience in working with Investigational Medicinal Products. 

Core Knowledge and Skill Requirements:  

• In-depth knowledge of GMP/GDPs and Data Management. 

• In-depth understanding of Quality principles, concepts, best industry practices, and international and industry standards (e.g. Data Integrity). 

• Strong Presentation Skills.  

• Experienced in managing projects towards process improvements. 

• Experienced working cross-region and departments with Clinical, Supply Chain, Regulatory, and Development 

• Spoken/Written fluency in English required. 

• Spoken/Written fluency in at least one of the following languages German/French/Italian preferred 

• Spoken/Written Mandarin is a plus 

Computer Skills:   

• PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio) 

• Veeva Vault Quality Docs; Veeva Vault Quality Suite; Veeva Submissions; SAP; IWRS; etc. 

Travel:  

• May travel occasionally 

• Ability to work on a computer for extended periods of time