质量合规经理 - 欧洲集群（兼职）
Quality Compliance Manager - Europe Cluster (Part-time)
加入EVA制药公司，这是一家致力于推动健康和福祉作为基本人权的领先制药公司。我们被认可并认证为最佳工作场所之一，致力于为员工营造支持性与创新性的环境。
职位概述
质量合规经理（兼职）负责维护并持续改进德国质量管理系统（QMS），确保符合德国和欧盟药品法规。该职位负责质量流程、检查、审计、培训、供应商资质、CAPA管理以及对外部合作伙伴的质量监督，以确保组织始终保持检查准备状态，并完全符合GxP要求。
主要职责
- 维护并持续改进本地质量管理系统（QMS）。
- 管理质量文件，包括标准操作规程（SOP）、表格、记录和定期审查。
- 协调员工培训、资质计划和合规记录。
- 领导供应商、客户和服务提供商的资质活动。
- 计划、执行并跟进内部审计和质量评估。
- 管理偏差、质量事件、CAPA和流程改进项目。
- 监督与制造商、外部服务提供商和批次放行合作伙伴相关的质量接口。
- 准备、协调并支持监管机构的检查，同时确保持续的检查准备状态。
用工类型
兼职 | 远程办公（德国本地）
要求
· 药学、生命科学或相关科学领域的学位。
- 在药品或医疗保健质量管理体系方面至少5-7年的工作经验。
- 在德国药品法（AMG §52a）下担任批发分销负责人经验。
- 熟悉GxP要求、德国药品法规和欧盟合规标准。
- 能够管理多项质量活动，并与内部和外部利益相关者有效互动。
最初发布于喜马拉雅山
查看英文原文
Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Job Summary
The Quality Compliance Manager (Part-Time) is responsible for maintaining and continuously improving the German Quality Management System (QMS), ensuring compliance with German and EU pharmaceutical regulations. The role oversees quality processes, inspections, audits, training, supplier qualification, CAPA management, and quality oversight of external partners to ensure the organization remains inspection-ready and fully compliant with GxP requirements.
Key Responsibilities
- Maintain and continuously improve the local Quality Management System (QMS).
- Manage quality documentation, including SOPs, forms, records, and periodic reviews.
- Coordinate employee training, qualification programs, and compliance records.
- Lead supplier, customer, and service provider qualification activities.
- Plan, conduct, and follow up on internal audits and quality assessments.
- Manage deviations, quality events, CAPAs, and process improvement initiatives.
- Oversee quality-related interfaces with manufacturers, external service providers, and batch release partners.
- Prepare for, coordinate, and support regulatory authority inspections while ensuring ongoing inspection readiness.
Employment Type
Part-Time | Remote (Germany-based)
Requirements
· Degree in Pharmacy, Life Sciences, or a related scientific discipline.
- Minimum 5-7 years of experience in pharmaceutical or healthcare quality management systems.
- Experience as a Responsible Person for Wholesale Distribution under German Medicines Act (AMG §52a).
- Strong knowledge of GxP requirements, German pharmaceutical regulations, and EU compliance standards.
- Manage multiple quality activities, and effectively interact with internal and external stakeholders.
Originally posted on Himalayas