Johnson & Johnson Careers
Quality Expert, Quality Systems
Requisition ID: 1905752842W
“Caring for the world … one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson pharmaceutical companies operating under the “Janssen Pharmaceutical Companies of Johnson & Johnson” trademark and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices.
Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.
Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson and is currently recruiting for a
The function holder is responsible to be the Site Subject Matter Expert of the Issue Management Process (CAPA/NCs/Escalations), Yearly Biologics Product Review Process and Quality Management Review processes. As the Super User for the QEM/REACT processes, you will support the training of site users and troubleshooting of any issues locally as well as driving continuous process improvements based on defined metrics. In addition, you will be responsible for the YBPR process and the Quality Site Management Review process execution as well as the management of other Quality Improvement projects in the site.
- Quality System Subject Matter Expert on End to End Issue Management Process (CAPA, Non-Conformances, Escalations) which includes both the QEM and REACT modules in TrackWise
- Inspection representative as subject matter expert for the End to End CAPA Process with responsibility for internal and external audit readiness
- Training and Coaching of Site Users in the End to End CAPA process
- Support the introduction of the CAPA Review Board process and continuous improvement projects relating to the End to End Issue Management Process based on defined KPIs
- Participation on Global Councils for QEM and REACT modules
- Manage the preparation and execution of the site Quality Site Management Reviews. Work with Site Leadership to assure effectiveness of the review process.
- Be responsible for the site YBPR process (Yearly Biologics Product Review). Partner with other Sites to assure execution of the reviews based on a predefined schedule.
- Drive other Quality Improvement projects in the site.
For this responsible position we are looking for a young professional with working experience in a highly regulated environment (FDA/EMEA/J&J standards and guidelines, general GMP guidelines), effective communication, leadership and interdependent partnering skills to be able to build an excellent internal and external network of development and production specialists.
- Bachelor or master’s degree in a technical or science discipline
- Two years of experience in a GMP regulated environment or experience in a relevant quality role
- Strong interpersonal skills able to train and communicate across multiple disciplines
- Team player, flexible and able to support and act as a backup for colleagues
- Advanced communiation skills in English (oral and written) Very good level of German both spoken and written.
You are a team-oriented, dynamic and highly motivated person with strong communication skills. For collaboration with different departments, sites and global teams you will need flexibility, social competence and a reasonable degree of authority. You will take decisions independently and provide advice as needed.
We are offering you a multifaceted challenge in a dynamic environment with attractive terms and an excellent infrastructure.
Cilag AG (8562)