Adrenomed AG is a highly innovative biopharmaceutical company based in the Berlin area, Germany. It is specialized in preserving vascular integrity in life-threatening conditions and is committed to precision medicine. The main focus is on sepsis and septic shock.
Currently, we have completed a Phase 2 clinical trial in septic shock and are planning to start a global Phase 3 pivotal trial with a subsequent market authorization.
We would never have come this far without our enthusiastic, creative, and highly motivated colleagues who are willing to grow and work in a dynamic environment. Exactly these colleagues are ready to welcome you to the team and support you from day one. We offer flat hierarchies and the possibility to directly contribute to the development of the company while also providing competitive salaries.
For our team we look for a Head of Quality Assurance f/m/d.
- lead the design and implementation of quality systems and processes including relevant quality standards, policies, procedures and KPIs required for a late-stage clinical development biotech company and oversee training in their use
- regulate the quality systems of the whole company, set coherent standards (Standard Operation Procedures; SOP) and monitor the measures taken by the different departments
- check if the organization, procedures, and operations within ADRENOMED AG adheres to the defined quality goals
- ensure that the guidelines of quality management are adhered to and correctly implemented with the quality team in cooperation with the responsible employee or cooperation partner, and the managing board of Adrenomed AG
- supervise the management of all quality relevant documents and records; performs the quality approval of the quality management regulated documents and analyses the effectiveness of the quality system
- manage data, document and material transfer to the contracted archiving vendor agreed with the responsible employee of the department.
- take over the administrative tasks of the electronic document management system for governing the controlled quality documents
- develop the quality planning and the resulting measures for quality control and quality assurance, together with the responsible employee of the department or contracted partners, as well as managing board
- support the managing board in organizing Management Review Meetings and organize internal audits
- coordinate of the internal activities for audits by external partners, inspections by authorities and the Due-Diligence processes by third parties
- update knowledge regarding current requirements and train employees those requirements within the training concept
- identify and monitor the resources for the agreed measures for quality assurance by managing board
- Graduated in life sciences
- Proven track record of successfully designing and implementing quality systems and processes in a life sciences research environment, ideally in a pharmaceutical or biotech company
- 5 years’ experience in Quality Management/ Quality Assurance in in clinical research and drug development in clinical research in at least one of the following areas in addition to Quality Management / Quality Assurance: Drug Regulatory Affairs, Pharmacovigilance/Drug Safety, Drug Supply, Project/Clinical Study Management
- Experience in a managerial position of at least 3 years in one of the above areas
- Very good knowledge of regulatory requirements for ADRENOMED AG as pharmaceutical company and sponsor of clinical studies
- Experience with national and international regulatory authorities
- Good communication with both verbal and written German and English.
- Good knowledge of MS Office programs (Word, Excel, PowerPoint, Teams)
Our commitments to you
- Opportunity to take part in a project that could change modern treatment options
- Innovative and international environment
- Flat hierarchies & fast decision times
- Implementation of your ideas
- Fair and competitive salary
- Good connection to Berlin’s public transport
- Up to 3 days of remote work per week
If you like this role and think that you would be a suitable candidate, don’t hesitate! Send us an application and CV to firstname.lastname@example.org