About Us
We are a research-driven biopharmaceutical company committed to the idea that by “following the science,” we can develop innovative medicines that significantly impact the world. Our dedication to world-class research empowers us to create medical and vaccine breakthroughs that improve the lives of patients globally.
Position Overview
This role reports to the Associate Director of Clinical Supplies Quality (Disposition Lead) and is essential for maintaining our global clinical supply chain through effective disposition activities for sourced drug products. These products are received through various channels to support the packaging activities of clinical finished goods used in trials worldwide. Key focus areas include the intricate details of clinical packaging, distribution activities, and compliance with regulatory requirements related to Investigational New Drug Applications and Clinical Trial Applications, particularly within complex supply chains.
Responsibilities
- Evaluate and dispose of clinical supply materials, ensuring compliance with all applicable company policies and governing regulations.
- Act as the primary contact for Sourced Drug Product releases and Shelf-Life Extensions for both ongoing projects and new initiatives.
- Coordinate quality control laboratory activities related to Sourced Drug Product testing.
- Support the preparation of procedures and processes for quality improvements.
- Assist in managing significant quality events, including investigation, clinical quarantine coordination, and recovery actions.
- Collaborate across functional and business areas to ensure robust processing and continuous improvement.
- Provide immediate support for operational and technical issues on the shop floor, addressing deviations as they arise.
- Lead projects to enhance process performance, focusing on continuous improvements and investigation of Corrective/Preventative Actions (CAPAs).
- Manage timelines for investigations, change requests, and projects, ensuring compliance and customer deadlines are met while escalating potential issues as needed.
- Champion Lean Six Sigma (LSS) methodologies within problem-solving and daily operations.
Your Profile
Education
- Bachelor's degree in a scientific or engineering field, or a closely related discipline is required.
Required Experience and Skills
- A minimum of 3 years of experience in the pharmaceutical or equivalent industry with a focus on Good Manufacturing Practice (GMP), including Technical, Engineering, Quality, or Operations roles.
- Strong familiarity with batch disposition activities is preferred; prior experience in this area is a plus.
- Experience in reviewing investigations, deviation management support, and CAPAs is considered a strong asset.
- Proficiency in Microsoft applications (Excel, Outlook, PowerPoint, Teams, OneNote, Access).
- Background in quality control, assurance, auditing, or regulatory affairs.
- Creative problem-solving skills and effective communication abilities.
- In-depth knowledge of current Good Manufacturing Practices (cGMPs) and relevant regulatory requirements.
- Leadership skills with well-developed oral and written communication capabilities.
- Strong teamwork skills and the ability to work independently with attention to detail.
Preferred Skills
- Ability to lead cross-functional teams, including engagements with senior management.
- Proven analytical and problem-solving abilities, alongside knowledge of Lean Six Sigma and Project Management principles.
- Competency in ERP/MES, Trackwise, SAP, with advanced knowledge in PowerPoint, Excel, and Word.
Our Commitment
At our company, quality assurance is paramount. We ensure that every component in our products is manufactured, processed, tested, packaged, stored, and distributed to meet our high quality standards and regulatory requirements. By partnering with internal manufacturing facilities and external suppliers, we maintain a reliable global manufacturing network that delivers compliant supplies to customers and patients worldwide.
Our Presence
Founded in Switzerland in 1963, our main operations are based in Lucerne, where approximately 1,000 employees collaborate across four locations. We have recently expanded to Zurich, focusing on the expedited development and commercialization of our medicines and vaccines. This expansion reflects our commitment to saving and improving lives globally.
Join Us
Imagine the experience of working in a role that significantly impacts lives globally. Here, you have that opportunity. Contribute your empathy, creativity, or scientific acumen while collaborating with a diverse team focused on hope and innovation against challenging diseases. If you are intellectually curious, we invite you to join us and begin making a difference today.
We celebrate the value of diversity and are committed to fostering an inclusive workplace. We encourage our colleagues to engage in thoughtful discussions and solve problems collectively. As an equal opportunity employer, we are dedicated to creating an inclusive and diverse work environment.
Apply online using the form below. Please note that only applications matching the job profile will be considered.