职位描述
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岗位职责: The Manager External Supply Quality is accountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements. This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer. Will operate as spokesperson for External Supply Quality and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers. The Manager External Supply Quality will have significant interactions with many internal business and manufacturing organizations (e.g., ES, GCMC, GTE, QO Center, PGS sites and PGRD) and will lead virtually based cross functional teams. 任职要求: Minimally BA/BS Science, Engineering, or related technical discipline with at least 8 years in a GXP setting. At least 4 years of Product Quality Assurance experience in a GMP environment. More than 2 years-experience with API/DS (Drug Substance) /DP (Drug Product) manufacturing and/or testing of large molecule products is required. Experience with external suppliers/contractors is preferred. Deep understanding of sterile operation is preferred. Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, and Documentum platforms. Command of English language required and multi-lingual is beneficial. Strong verbal and written communication including presentation skills. Shows strong negotiation skills and is diplomatic in communication with internal and external customers. Demonstrated ability to manage multiple projects. Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader. Have excellent organization skills. Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor. Developing personal leadership to manage cross functional projects. Developing ability to resolve conflicts. Takes initiatives and is proactive, persistent. Has a broad GMP and technical know-how to handle emerging issues.