By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **About the Role:** The Quality Assurance Expert is responsible for ensuring compliance and quality oversight throughout the manufacturing and release process of Drug Product (DP). This role plays a critical part in maintaining the highest standards of Good Manufacturing Practices (GMP), working collaboratively with various departments to ensure product integrity and regulatory adherence. **How You Will Contribute:** + Act as QA representative for routine GMP activities and company projects (including the implementation of a new manufacturing area) + Ensure compliance with internal procedures, regulatory requirements, and industry best practices + Lead and review deviation investigations, impact assessments, and corrective/preventive actions (CAPA) + Evaluate and approve change controls, ensuring smooth implementation and compliance + Provide quality oversight by supporting and guiding production teams directly on the shopfloor + Conduct internal GMP audits and participate in regulatory inspections + Prepare, evaluate, and approve controlled documents (SOPs, forms, specifications, etc.) + Participate in batch record review and release activities + Support continuous improvement initiatives and contribute to operational efficiency + Provide training on GMP, GDP, and quality-related topics **Skills and Qualifications:** + Bachelor/Master’s degree in Engineering, Biotechnology, Pharmacy, or Quality Management + 2-5 years of experience in a GMP environment within the pharmaceutical or biotechnological industry + Strong understanding of GMP, FDA, EMA, ICH, and Pharmacopeia regulations + Experience in auditing, inspection preparation, and deviation management + Knowledge of biotechnological processes and manufacturing operations, and more specifically aseptic process + Proficiency in MS Office; experience with quality systems such as TrackWise, Veeva and PAS-X is a plus + Fluent in French; intermediate level in English **Personal Attributes:** + Detail-oriented with strong analytical skills + Structured, organized, and able to manage priorities in a fast-paced environment + Proactive and solution-oriented mindset with a continuous improvement approach + Excellent communication skills, able to adapt to different stakeholders + Team player, fostering collaboration across departments **Complexity and Problem Solving:** + Participate in operational decision-making + Evaluate change requests and deviations in alignment with regulatory requirements and internal procedures + Ensure compliance with validation reports, SOPs, and industry regulations **Why Join Us?** At Takeda, we are dedicated to transforming patient care through innovative medicines and first-class support programs. As a Global Top Employer, we offer stimulating careers, encourage innovation, and uphold excellence in everything we do. Our inclusive and collaborative environment empowers employees to thrive and contribute to a brighter future for all. **Locations** CHE - Neuchatel **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time