Job Summary
The GMP Support Lead is a key technical and leadership role within the Drug Product Manufacturing Science & Technology (MSAT) team. This position ensures compliance with Good Manufacturing Practices (GMP) and regulatory requirements while driving continuous improvement in manufacturing processes, quality systems, and operational excellence. The role involves collaborating with cross-functional teams (e.g., Quality, Engineering, Operations, Regulatory Affairs) to support product launches, troubleshoot manufacturing issues, and implement innovative solutions.
Key Responsibilities:
Provide technical support for manufacturing operations, ensuring adherence to GMP and regulatory requirements (e.g., FDA, EMA, NMPA).
Collaborate with cross teams to optimize production processes, troubleshoot deviations, implement corrective actions, and initiate change control.
Lead sterility assurance activities, including smoke study, and aseptic process simulation, etc.
Support external regulatory inspections (e.g., FDA, EMA) by preparing audit responses and facilitating communication.
Work closely with Quality, Production, and Engineering teams to address GMP-related issues and streamline workflows.
Participate in risk assessments (e.g., FMEA) and contribute to continuous improvement initiatives for GMP compliance.
Requirements:
Bachelor’s degree or above in Pharmacy, Biotechnology, or related field; familiarity with GMP guidelines. No less than 10 years related working experience with fluent English.
Strong analytical skills and attention to detail in documentation review and audit preparation.
Ability to communicate effectively in cross-functional settings and adapt to dynamic regulatory environments.
职位概述
GMP 支持主管是药品生产制造科学与技术（MSAT）团队中的关键技术和领导角色。该职位确保符合良好生产规范（GMP）和监管要求，同时推动制造流程、质量体系和运营卓越的持续改进。此角色需要与跨职能团队（例如质量、工程、运营、法规事务）合作，支持产品上市、解决制造问题并实施创新解决方案。
主要职责：
- 为生产操作提供技术支持，确保符合 GMP 及监管要求（例如，美国食品药品监督管理局、欧洲药品管理局、国家药品监督管理局）。
- 与跨部门团队合作，优化生产流程，解决偏差问题，实施纠正措施，并启动变更控制。
- 主导无菌保证活动，包括烟雾研究和无菌工艺模拟等。
- 通过准备审核回复和促进沟通，支持外部监管检查（例如，美国食品药品监督管理局、欧洲药品管理局）。
- 与质量、生产和工程团队密切合作，解决与 GMP 相关的问题，并优化工作流程。
- 参与风险评估（例如，失效模式与影响分析），并为持续改进 GMP 合规性的工作做出贡献。
要求：
药学、生物技术或相关专业本科及以上学历；熟悉 GMP 指南。具有不少于 10 年相关工作经验，英语流利。
具备出色的分析能力和细致的文档审查及审计准备能力。
能够在跨职能环境中有效沟通，并适应动态的监管环境。