Roles and Responsibilities

Act as the registered primary Responsible Person (Fachtechnisch verantwortliche Person – FvP) for import and export in accordance with the Medicinal Products Licensing Ordinance of 01 September 2023 (MPLO/AMBV Part 2, Art. 13, 17, 18) and ensure the safe trading of medicinal products in Switzerland.

Main responsibilities as RP include but are not limited to:

• Partnering and collaborating with local stakeholders to ensure that all Quality activities are done in accordance with Swiss law, EU GDP and EU GMP, Global Quality Policies and Compliance Systems.
• Being responsible for the execution, development and maintenance of the local Quality Management System at Daiichi Sankyo Switzerland (DSCH), in accordance with Swiss law, EU GMP and GDP regulations.
• Providing experience, mature judgment to site leadership in routine supply activities, new product introductions and projects, and advice on quality matters.
• Acting as a Quality liaison between the local operational groups and Corporate Quality for GMP and GDP functions and activities.
• Deciding on the release or rejection of batches of medicinal products for the Swiss Market and ensuring that the released pharmaceutical products meet the product specifications and are manufactured in accordance with GMP.
• Acting as the point of contact for customers and regulatory authorities on specialist pharmaceutical matters.
• Reviewing and approving QMS-related activities (e.g. SOPs, investigations of local/global non-conformities, Changes and Quality Complaints, Risk Assessments).
• Taking action in the event of medicinal product recalls, and authorising and suspending medicinal products.
• Conducting a Product Quality Review of all products marketed in Switzerland for the company management.
• Supporting DSE's subsidiary QA in creating change controls, nonconformities, and related actions in the electronic quality management system (eQMS).
• Taking action in the event of medicinal product recalls, and authorising and suspending medicinal products.
• Conducting a local review of the Product Quality Review of all products marketed in Switzerland for the company management.
• Promoting Quality Culture at the Swiss Affiliate and fostering a proactive approach to compliance.

Education & Experience

Education:

• University degree in Life Sciences (BSc, MSc or PhD) in Pharmacy, Chemistry, Biology, or a related scientific discipline. 
• Eligible to act as a Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) under Swiss regulatory requirements (see I-SMI.TI.17e), with the professional qualifications and experience required for Swissmedic recognition. 
• Strong expertise in GMP and GDP regulatory requirements, with sound judgement in quality-critical matters and a solid understanding of manufacturing processes and customer requirements. Fast comprehension with an ability to apply new ideas, concepts and methods. 

Experience:

• 5 to 8 years: At least 5–8 years of experience in quality management in a GMP/GDP-regulated environment. 
• Knowledge of SAP HANA would be an advantage. 

Skills and additional Requirements

• Fluency in English and German (written and spoken). Knowledge of French and Italian would be advantageous.
• Confident use of Office programs and database systems. 
• Independent and accountable personality with a goal- and solution-oriented mindset. 
• Very good interdisciplinary and cross-cultural communication skills and strong decision-making skills. 
• Excellent social competence and a team player. 
• Knowledge of SAP HANA would be an advantage.