Sr. Quality Manager Fachtechnisch Verantwortliche Person; FvP); m​/f​/x

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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 judgement 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

• 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 Swiss medic 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.

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas.

If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.