Specialist Clinical Supplies Quality Assurance (male/female)

About Us

We are a research-driven biopharmaceutical company, committed to the belief that by "following the science," we can create transformative medicines that significantly impact the world. Our mission centers on fostering a research-driven enterprise dedicated to world-class science, pioneering medicine and vaccine innovations that improve the lives of patients across the globe.

Position Overview

This position reports to the Associate Director of Clinical Supplies Quality (Disposition Lead) and plays a vital role in maintaining the global clinical supply chain through disposition activities for sourced drug products. These products are received through various channels (internal and external) to facilitate the packaging of clinical finished goods that support worldwide clinical trials. The areas of focus include the detailed workings of clinical packaging, distribution activities, and the associated regulatory requirements for Investigational New Drug applications and Clinical Trial Applications related to complex supply chains and clinical protocols.

Responsibilities

• Evaluate and dispose of clinical supply materials, ensuring compliance with all applicable policies and governing regulations.
• Act as the point of contact for sourced drug product releases and shelf-life extensions, including ongoing projects and new initiatives.
• Support and coordinate quality control laboratory activities related to sourced drug product testing.
• Assist in the development of procedures, processes, and quality improvements.
• Coordinate significant quality events, including fact-finding, investigations, and recovery actions.
• Collaborate across functional and business areas to enhance processing, continuous improvement, and team dynamics.
• Provide on-the-ground support for operational and technical issues, addressing deviations promptly.
• Lead projects focused on process performance improvements, including CAPAs and initiatives aimed at optimizing yield and reducing costs.
• Manage investigation timelines and project deadlines to meet compliance and delivery standards, escalating issues and devising remediation plans as necessary.
• Advocate for the use of Lean Six Sigma (LSS) and our Company’s Production System tools in daily operational activities.

Your Profile

Education

• Bachelor's degree in a technical field such as science or engineering, or a closely related area.

Required Experience and Skills

• Minimum of 3 years’ experience in the pharmaceutical industry or a related field, including Good Manufacturing Practice (GMP).
• Strong familiarity with batch disposition activities is highly preferred.
• Experience in reviewing investigations, deviation management support, and CAPAs.
• Basic proficiency in Microsoft applications such as Excel, Outlook, PowerPoint, Teams, and/or Access.
• Background in quality control, quality assurance, auditing, or regulatory affairs.
• Effective problem-solving skills with a creative approach.
• In-depth knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
• Demonstrated leadership abilities combined with strong communication skills, both oral and written.
• Proven ability to work independently and as part of a team, along with excellent attention to detail.

Preferred Skills

• Ability to lead cross-functional teams, including senior management.
• Demonstrated analytical and problem-solving capabilities, with knowledge of Lean Six Sigma and Project Management.
• Familiarity with ERP/MES systems, Trackwise, SAP, PowerPoint, Excel, and Word.

Our Commitment to Quality

Our Quality Assurance group ensures that all materials in our products are manufactured, processed, tested, packaged, stored, and distributed in accordance with our high standards of quality and regulatory requirements. Partnering with our internal manufacturing facilities and external suppliers, we create a robust global network dedicated to delivering a compliant and reliable supply of products to customers and patients worldwide.

The Company

Established in Switzerland in 1963, our regional office and manufacturing facility in Lucerne serves as the operational hub, employing approximately 1,000 professionals across four locations. A new site has been opened in Zurich to accelerate the development and commercialization of our medicines and vaccines, further supporting our mission to enhance lives globally.

Join Us

Imagine waking up each day knowing your work contributes to saving and improving lives worldwide. Here, you have that opportunity to apply your skills in collaboration with a diverse team dedicated to tackling some of the most challenging health issues of our time. We are seeking those who are intellectually curious and ready to make an impact.

We celebrate diversity and are committed to fostering an inclusive workplace. We believe that breakthrough innovation occurs when diverse ideas converge in an inclusive environment. We invite you to apply online using the form below. Only applications matching the job profile will be considered.