Senior Manager, Distribution Quality
1 week geleden
BeiGene 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:
This position reports to the Senior Director Distribution Quality. The incumbent provides GDP/GSP expertise and manage day-to-day operations for distribution of IMPs and commercial products globally for BeiGene, ensuring that clinical and commercial products are supplied in accordance with regulatory expectations and applicable quality standards.
Essential Functions of the job:
Point of Quality contact and manage distribution quality related activities, including cold chain, lane risk assessment, shipping validation, change control, deviations investigation, temperature excursion within the distribution network providing timely resolution and escalation as needed. Management and oversight of global distributions and logistics service providers. Provide guidance to supply chain and distribution operations teams to ensure GDP/GSP compliance. Cultivate productive and collaborative relationships across functional areas and geographies, including Commercial, Pharmacovigilance, Medical, Supply Chain, Operations, Internal and External Supply Quality, Regional Quality, Quality Management Systems and Affiliate quality teams. Enhance GDP/GSP knowledge and understanding throughout the organization, ensuring compliance with industry requirements, standards, and best practices. Support fostering a culture of continuous improvement and excellence in quality management, provide training and support development of staff on GDP/GSP requirements, as needed. Establish and monitor key performance metrics of supply chain and distribution processes, including logistics service providers. Ensure inventory management and oversight is available in SAP. Support audits and inspections to ensure GDP/GSP compliance.Qualifications:
Bachelor’s degree in science or a combination of education and equivalent work experience More than 5 years pharmaceutical or biotechnology industry experience Experience with Good Distribution Practice (GDP/GSP) in a quality function Strong knowledge of Good Manufacturing Practices (GMP) Excellent attention to details Ability to effectively manage time and progress tasks to meet timelines in a fast-paced/dynamic environment. Effective oral and written communication skills Experienced working cross-department Ability to work independently.Computer Skills:
PC literate with MS Office skills (Outlook, Word, Excel, PowerPoint) Veeva Quality Docs, Veeva Quality Suite, SAP.BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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-
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