R356624 Specialist Clinical Supplies Quality Assurance (m/f/d)

About Us

We are a research-driven biopharmaceutical company committed to the belief that by “following the science,” we can develop great medicines that significantly impact the world. Our mission is to succeed by inventing innovative medicines and vaccines that benefit patients globally.

Position Overview

This role is pivotal in maintaining our global clinical supply chain through disposition activities for clinical finished goods. It involves packaging activities supporting our company’s clinical trials worldwide, fostering a dynamic cross-functional environment with multiple stakeholders across different countries.

Key Responsibilities

• Review and release incoming label stock.
• Review and release clinical finished goods, ensuring the accuracy of fully printed and applied labels.
• Conduct GMP reviews of electronic batch records and prepare clinical finished good Batch Certificates for approval by the Swiss Responsible Person (RP).
• Perform regulatory reviews of packaged clinical finished goods to ensure compliance with regulatory filings.
• Collaborate with internal functional areas, including Manufacturing, Packaging, Labelling, Operational Planning, and more, as well as external partners such as Contract Manufacturing Organizations and Contract Research Organizations.
• Communicate any issues that may delay or prevent timely release to the relevant management and qualified personnel.
• Demonstrate accuracy and effective time management, ensuring timely supply of clinical drugs to patients, while maintaining professional and precise communication with stakeholders.

Qualifications

Education

Bachelor's or higher degree in a technical field related to science or engineering is required.

Experience and Skills

• A minimum of 3 years of experience within the pharmaceutical or related industry, particularly in GMP, Technical, Engineering, Quality, or Operations fields.
• Familiarity with batch disposition activities is strongly preferred.
• Experience in reviewing and approving investigations, deviations, and Corrective/Preventative Actions (CAPAs) is advantageous.
• Basic proficiency in Microsoft applications (Excel, Outlook, PowerPoint, Teams, OneNote, Access).
• Creative and effective problem-solving abilities.
• Comprehensive knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements in the pharmaceutical field.
• Strong leadership, oral and written communication skills, along with interpersonal and conflict resolution abilities.
• Demonstrated teamwork capabilities and the ability to work independently.
• Attention to detail, flexibility, and awareness of production and quality control challenges.
• Ability to manage multiple priorities and projects independently.

Preferred Skills

• Experience leading cross-functional teams, including senior management representatives.
• Proficient in analytical and problem-solving methodologies such as Root Cause Analysis and Lean Six Sigma.
• Knowledge of ERP tools, deviation management systems, and office applications such as Veeva, Trackwise, SAP QN, SAP, PowerPoint, Excel, OneNote, and Word.

Our Commitment to Quality

Our Quality Assurance group ensures that every material within our products is manufactured, processed, tested, packaged, stored, and distributed according to our high standards of quality, meeting all regulatory requirements. By partnering with both internal manufacturing facilities and external suppliers, we create a reliable global manufacturing network dedicated to delivering compliant and timely supplies to customers and patients around the world.

Our Site

Our Werthenstein BioPharma site in Schachen is a hub for innovative research, where we develop and analyze new biological agents. We produce new products and supply clinical trial materials for global studies, supported by one of our global forensic laboratories that monitor our products through the supply chain to ensure their security and safety for patients.