For our client, a global leading pharmaceutical company in Switzerland, we are looking for a GMP Compliance Manager.
General Information:
- Start date: ASAP
- Latest possible start date: 01.09.2025
- Duration: 12 months with the possibility of extension
- Workplace: Kaiseraugst
- Workload: 100%
- Remote/home office: Yes, max 50%
- Team: 10 people
- Department: Global Clinical Supply Chain Operations
- Working hours: Standard
About the job:
The mission of the Global Clinical Supply Chain Organisation (GCSC-O) is to cost-effectively ensure that the right product is in the right place at the right time, so that no patient is left without treatment and no clinical trial is delayed.
Clinical Supply Chain Management is responsible for the supply of all global clinical trials across the entire life cycle of our products. Clinical packaging operation works closely with customers and suppliers to offer the best possible services in terms of lead time, flexibility, and cost-effectiveness. Organization includes demand and supply planning, the development of patient kits based on study protocols, as well as the operational aspects of packaging, distribution, and inventory management.
In the role of GMP Compliance Manager, you will ensure that cGMP regulations and guidelines are incorporated into all our packaging, logistics, and support processes within the Operations Team. This also includes aspects of qualification and validation. This will make a significant contribution to the quality of our products.
Your Profile:
The "ideal candidate" will either have a completed technical education with several years of professional experience in a GMP-regulated manufacturing company or a degree in life sciences or engineering with initial professional experience in a GMP-regulated manufacturing company. Sound knowledge of operational processes and facilities, as well as change and deviation management, is required. Initial professional experience in driving continuous improvement processes is also required.
Tasks & Responsibilities:
- Independent processing of GMP activities in the packaging operation
- Processing of deviations, planned events and CAPA etc.
- Creation and revision of documents such as SOPs and other process and plant-specific instructions
- Conducting GMP training and further development of the GMP knowledge of the employees in the clinical packaging operation
- Support and/or management of projects in the GMP-regulated environment, e.g. in the
- Procurement of new equipment or systems as well as the implementation of new processes
- Close cooperation with interfaces such as engineering, quality, planning, logistics, etc.
Must Haves:
- Completed technical apprenticeship with several years of professional experience or a completed degree in the field of life science or engineering with initial professional experience
- At least initial professional experience in a cGMP production environment, preferably in packaging and inspection or warehouse logistics processes
- Knowledge of cGMP standards
- Initial experience with internal (PTQ) or external (e.g. FDA, EMA) inspections
- Good technical understanding and the ability to understand and define processes
- Fluent in written and spoken German and English
- Strong interpersonal, communication, organizational and prioritization skills
- Strong focus on customer needs
- Knowledge of Google applications, computer programs MS Word/Excel/PowerPoint, Visio and systems such as SAP, Cornerstone, Veeva
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
Application Submission Deadline: 15.07.2025
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