Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
QA Logistics is committed to actively support logistics operations to ensure cGDP compliant processes through the supply chain globally.
The position holder works independently and reports to the As. Director QA Logistics (Responsible Person of Celgene Logistics).
He/she closely works together with internal stakeholders (Celgene Logistics and other Celgene sites and affiliates) and vendors (Logistics Contract Service Providers) to ensure compliance with quality standards.
Excellent communication skills as well as commitment to Celgene values are required to foster positive relationships both internally and externally.
Duties and Responsibilities Quality Vendor Management for International Logistics CSPs (transport companies, distributors, logistics service providers, marketing partners): Management of logistics issues (deviations) / CAPA / Change control management. Update/create Technical and Quality Agreements. Monitor quality performance of CSPs/KPIs – vendor annual assessment. Contributes to the maintenance of the Celgene Logistics Quality Management System (QMS) by writing, reviewing and by making recommendations for revision of QMM documents (SOPs, Policies, Working Practices, etc). Ensure GMP/GDP compliance in local manipulations/labelling operations. Works closely with stakeholders (Celgene Logistics, Product Security, affiliates, operational sites) to ensure GDP compliance in logistics Operations. Ensure support for new logistics set-up/flows, new product/market launches, etc Transportation quality SME. Supports / lead Transport validation / qualification activities. Owner of temperature monitoring process and relationship with the technology vendor. Owner of route mappings. Support Mock recall annual exercise. Support Regulatory inspections for Celgene sites and Affiliates as GDP expert. Deputy of As. Director QA Logistics (Responsible Person Celgene Logistics) as appropriate. Supports to cross-functional projects with Supply Chain/logistics scope (EU distribution, Cold Chain, Serialization, etc) Supports/lead risk Assessments within supply chain area.
Definitions and Abbreviations
QA: Quality Assurance
QMS: Quality Management System
CSP: Contract Service Provider
LSP: Logistic Service Provider
GDP: Good Distribution Practices
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.