Company Overview
We are a research-driven biopharmaceutical company committed to the belief that "following the science" can lead to the development of groundbreaking medicines that have a significant impact on the world. Our focus on world-class research enables us to innovate medicine and vaccine solutions that improve the lives of patients globally.
Position Overview
This position reports to the Technical Lead in the Clinical Supplies Quality Disposition Group and plays a critical role in maintaining the global clinical supply chain through disposition activities for clinical finished goods. This role supports packaging activities vital for our worldwide clinical trials. You will thrive in a dynamic cross-functional work environment, collaborating with multiple stakeholders across various countries.
Key Responsibilities
- Review and release incoming label stock.
- Review and release clinical finished goods, including detailed assessment of fully printed and applied labels.
- Perform GMP review of electronic batch records and prepare clinical finished goods Batch Certificates for Swiss Responsible Person (RP) approval.
- Conduct regulatory reviews of packaged clinical finished goods to ensure compliance with regulatory filings.
- Collaborate closely with internal functions such as Manufacturing, Packaging, Labelling, Operational Planning, and Clinical Quality, as well as external partners including Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).
- Communicate any issues that may delay or prevent timely release of products.
- Address batch-related issues with management, EU Qualified Persons, and the Swiss Responsible Person (FvP).
Education
A Bachelor's or higher degree in a technical field related to science, engineering, or related disciplines is required.
Required Experience and Skills
- A minimum of 3 years of experience in the pharmaceutical or equivalent industry, particularly in a Good Manufacturing Practice (GMP) environment, encompassing Technical, Engineering, Quality, or Operations roles.
- Familiarity with batch disposition (release) activities is strongly preferred.
- Prior experience in reviewing and approving investigations, deviation management, and Corrective/Preventative Actions (CAPAs) is advantageous.
- Basic proficiency with Microsoft applications including Excel, Outlook, PowerPoint, Teams, OneNote, and/or Access.
- Demonstrated creativity and effectiveness in addressing and solving technical problems.
- In-depth understanding of current Good Manufacturing Practices (cGMPs) and applicable regulatory requirements in the pharmaceutical field.
- Exemplary leadership, oral and written communication abilities, and interpersonal conflict resolution skills.
- Strong teamwork skills complemented by the ability to work independently.
- Attention to detail with flexibility and awareness of potential production and quality control issues; capability to manage multiple priorities and projects effectively.
Preferred Skills
- Experience in leading and supporting cross-functional and multi-level teams, including representation from senior management.
- Demonstrated analytical and problem-solving abilities, along with knowledge of Root Cause Analysis, Lean Six Sigma, and Project Management.
- Competence in ERP (Enterprise Resource Planning) Tools, deviation management systems, document management systems, and other office tools such as Veeva, Trackwise, SAP QN, SAP, PowerPoint, Excel, OneNote, and Word.
Join Us
Our Quality Assurance group ensures that every material used in our products is manufactured, processed, tested, packaged, stored, and distributed in accordance with our high standards of quality and all regulatory requirements. We collaborate with our internal manufacturing facilities, external contract manufacturers, and suppliers to create an interdependent global manufacturing network that consistently delivers a compliant and reliable supply to customers and patients worldwide.
At our Werthenstein BioPharma site in Schachen, we conduct cutting-edge research, develop and analyze new biological agents, and produce clinical trial products for global studies. The site is also home to one of our global forensic laboratories, where we meticulously monitor our products throughout the supply chain to ensure security and safety for patients.
Apply online using the form below. Only applications matching the job profile will be considered.