As a part-time Quality & Process Manager (m/f/d), you will work closely with the leadership team to design an integrated management system that transforms quality, efficiency, and regulatory excellence into a strategic competitive advantage for the company. Your goal is to create an organization in which processes are understood not as bureaucratic requirements, but as the foundation for outstanding consulting services in the AMNOG and market access environments.
You will develop a transparent, scalable, and audit-ready quality and process management system that meets the high standards of clients, regulatory agencies, and other stakeholders. In doing so, you support the functional departments in implementing complex projects efficiently, transparently, and to a consistently high standard of quality.
Through the continuous analysis, standardization, and optimization of business processes, you foster a culture of continuous improvement. You ensure that knowledge is systematically captured, best practices are established, and risks are identified early on.
Quality & Process Manager (Specialist) (m/f/d)
SmartStep Consulting - Hamburg
Part-time
Permanent employee
Our vision
Your mission
- Further development and maintenance of our Integrated Management System (IMS) in accordance with ISO 9001:2015 and other relevant standards and regulatory requirements
- Analysis, optimization, and documentation of business processes to continuously improve company operations
- Creation, maintenance, and further development of policies, processes, work instructions, and quality management documentation
- Planning, conducting, and following up on internal audits and events as part of quality management
- Advising and supporting business units on quality-related issues and process optimization
- Designing and conducting training sessions on quality management and process management topics
Your profile
- A successfully completed degree in quality management, business administration, industrial engineering, health care management, or a comparable field
- Several years of experience in quality and process management, ideally in a service-oriented or regulated health care setting
- In-depth knowledge of ISO 9001:2015, as well as practical experience in preparing for and conducting audits
- Experience in establishing, further developing, or maintaining management systems
- Knowledge of information security (e.g., ISO 27001) is a plus
- Proficiency in using documentation and collaboration systems such as Confluence or comparable solutions
- A high degree of initiative, analytical thinking, and problem-solving skills, combined with a meticulous and reliable work ethic
- Business-level proficiency in spoken and written German and English
Why us?
We offer you the opportunity to work as part of a dynamic and highly qualified team, exciting and varied projects in one of the “hot topics” of the healthcare sector, and compensation commensurate with your performance. In addition, we provide targeted employee development, continuing education through our own SmartStep Academy, and opportunities to develop your personal skills.
About us
SmartStep Consulting offers customized, highly specialized services for the pharmaceutical and medical technology industries to enable patients quick access to new and better treatment options. As part of the G&L Group, SmartStep aims to expand its services and leverage international opportunities arising from the new EU-HTA procedures.