QMS项目经理
QMS Project Manager
职位描述
作为项目经理，您将指导生命科学领域的客户完成数字化质量转型。您将全程负责eQMS的实施，指导客户遵循质量最佳实践，并确保每个项目都能实现可衡量的价值。
如果您熟悉生命科学领域的法规和质量流程，具备技术思维，喜欢进行演示和培训，并能自信地用英语沟通，那么您会在这里茁壮成长。
主要职责
- 全程领导客户实施项目，确保范围、时间表和质量目标按计划推进。
- 与客户合作，围绕其业务和合规需求配置和优化Dot Compliance解决方案。
- 在整个项目生命周期中分享最佳实践并提供战略指导。
- 组织培训课程、研讨会和持续辅导，帮助客户建立持久的质量管理能力。
- 制定并维护详细的工作计划、时间表、估算和资源分配。
- 跟踪项目进展，尽早发现风险，并推动主动应对措施。
- 使用人工智能驱动的工具加速客户交付成果——项目计划、配置文档和培训材料——同时不牺牲准确性、质量和合规性。
- 成为客户的可信顾问，建立长期客户关系，超越实施阶段。
要求
资格条件
- 在生命科学领域有7年以上专业服务、客户成功或项目管理经验。
- 对制药、生物技术和/或医疗器械领域的法规要求和质量流程有深入了解（例如ISO 13485、FDA 21 CFR Part 11）。
- 具有eQMS实施经验，最好是在基于Salesforce的平台上。
- 有管理复杂项目和带领跨职能团队的经验。
- 科学、工程、工商管理或相关领域的学士学位。
- 英语书面和口头表达能力优秀（懂德语或法语者优先）。
- 强大的问题解决、组织和利益相关者管理能力。
加分项
- 具有Dot Compliance或其他类似基于云的QMS平台的经验。
- 熟悉Salesforce CRM或Force.com平台。
- 拥有PMP、PRINCE2或同等项目管理认证。
最初发布于喜马拉雅山
查看英文原文
Description
As a Project Manager, you will guide life sciences customers through their digital quality transformation. You will own eQMS implementations end to end, coach customers on quality best practices, and make sure every project delivers measurable value.
You will thrive here if you know your way around life sciences regulatory and quality processes, are technically minded, enjoy presenting and training, and communicate with confidence in English.
Key Responsibilities
- Lead customer implementation projects end to end, keeping scope, timelines, and quality objectives on track.
- Partner with customers to configure and optimize Dot Compliance solutions around their business and compliance requirements.
- Share best practices and provide strategic guidance across the full project lifecycle.
- Run training sessions, workshops, and ongoing coaching build lasting quality management capability on the customer side.
- Build and maintain detailed work plans, schedules, estimates, and resource allocations.
- Track progress, surface risks early, and drive proactive mitigation.
- Use AI-powered tools to accelerate customer deliverables — project plans, configuration documentation, and training materials — without compromising accuracy, quality, or compliance.
- Act as a trusted advisor and build long-term customer relationships that outlast the implementation.
Requirements
Qualifications
- 7+ years in professional services, Customer Success, or project management within the life sciences sector.
- Strong grasp of regulatory requirements and quality processes across pharma, biotech, and/or medical devices (e.g., ISO 13485, FDA 21 CFR Part 11).
- Experience with eQMS implementation, preferably on Salesforce-based platforms.
- Demonstrated ability to manage complex projects and lead cross-functional teams.
- Bachelor’s degree in science, Engineering, Business Administration, or a related field.
- Excellent written and verbal communication in English (German or French a plus).
- Strong problem-solving, organizational, and stakeholder management skills.
A+ if you meet these requirements
Bonus Points
- Experience with Dot Compliance or similar cloud-based QMS platforms.
- Familiarity with Salesforce CRM or Force.com platform.
- PMP, PRINCE2, or equivalent project management certification.
Originally posted on Himalayas