Join Our Team
We are a research-driven biopharmaceutical company committed to making a significant impact on the world through innovative medicines and vaccines. Our mission is simple: by "following the science," we aim to deliver world-class healthcare solutions for patients across the globe.
Position Overview
This role reports to the Associate Director of Clinical Supplies Quality (Disposition Lead) and is crucial for maintaining our global clinical supply chain. You will play a vital part in the disposition activities for sourced drug products, ensuring effective packaging operations for our clinical trial needs. Key areas of focus in this position include the intricate details of clinical packaging, distribution logistics, and compliance with regulatory requirements associated with Investigational New Drug applications and Clinical Trial Applications.
Key Responsibilities
- Evaluate and ensure the disposition of clinical supply materials in compliance with company policies and regulatory standards.
- Act as the primary contact for Sourced Drug Product releases and Shelf-Life Extensions, managing both ongoing projects and new initiatives.
- Support and coordinate quality control laboratory activities related to Sourced Drug Product testing.
- Assist in preparing procedures, processes, and quality improvement initiatives.
- Coordinate significant quality events, including investigations and clinical quarantine actions.
- Collaborate across functions and business areas to promote continuous improvement and effective team dynamics.
- Provide immediate support on the shop floor for operational and technical issues related to deviations.
- Complete projects aimed at enhancing process performance, including CAPAs and value capture initiatives.
- Manage timelines for investigations and change requests to meet compliance and customer deadlines, while developing remediation plans as necessary.
- Champion the use of Lean Six Sigma (LSS) and our Company's Production System tools in daily operations.
Your Profile
Education
- Bachelor's degree in a technical field such as science or engineering.
Required Experience and Skills
- A minimum of 3 years’ experience in the pharmaceutical industry or a related field, with a focus on Good Manufacturing Practices (GMP).
- Familiarity with batch disposition activities is strongly preferred.
- Experience in investigations, deviation management, and CAPAs is a plus.
- Basic proficiency in Microsoft applications (Excel, Outlook, PowerPoint, Teams, OneNote, Access).
- Background in quality control, quality assurance, or regulatory affairs.
- Strong analytical and problem-solving abilities.
- In-depth understanding of current Good Manufacturing Practices (cGMPs) and relevant regulatory requirements.
- Exceptional verbal and written communication skills, alongside effective interpersonal skills.
- Demonstrated ability to work collaboratively and independently in a fast-paced environment.
- Attention to detail and the capability to manage multiple priorities and projects.
Preferred Skills
- Ability to lead cross-functional teams, including senior management representatives.
- Demonstrated leadership and project management skills.
- Proficiency with ERP/MES, Trackwise, SAP, and Microsoft applications.
About Us
Our Quality Assurance team ensures that every material used in our products meets our rigorous quality standards while complying with all regulatory requirements. We partner with internal manufacturing facilities and external suppliers to create a reliable global manufacturing network dedicated to delivering quality healthcare products to patients worldwide.
The Company
Established in Switzerland since 1963, our company operates from regional offices and manufacturing facilities in Lucerne, employing approximately 1,000 dedicated professionals. We are committed to accelerating the development and commercialization of life-saving medicines and vaccines. Recently, we opened a new location in Zurich aimed at furthering our mission.
As a certified “Top Employer Switzerland” and “Top Employer Europe,” we demonstrate our dedication to fostering a supportive environment for our employees and the surrounding community.
Our Commitment
At Merck & Co., Inc., we strive to invent solutions that improve lives. If you seek a role where your work makes a difference, where you can collaborate with a diverse team to tackle challenging diseases, we invite you to join us. Embrace the opportunity for innovation and contribute to a collaborative and inclusive workplace.
Apply online using the form below. Please note that only applications matching the job profile will be considered.