The Quality Responsible Person (QRP) / Fachtechnisch Verantwortliche Person (FvP) based in Zug, Switzerland is responsible for the direct supervision of the Swiss Entity in order to ensure compliance at any time with the legal requirements, in accordance with the Swiss law on Medicinal Products. Acting as the Quality Responsible Person and specifically fulfilling the requirements of Medicinal Products Licensing Ordinance (SR 812.212.1), article 5, article 6, article 17, article 18, article 22, article 23, article 25, article 26 and article 39. Working collaboratively as part of the Quality Operations team to ensure we deliver a compliant, reliable supply to customers and patients on time, every time, in the territory.
- Define and implement the quality management system (QMS) at the Swiss affiliate in accordance with the Swiss Therapeutic Products Act (SR 812.21) for Medicinal products.
- Ensuring the attainment and maintenance of the Swiss affiliate Pharmaceutical Establishment Licence
- Prepare for and maintain a status of Inspection readiness for Inspections by Swiss Medic
- Participate in Health Authority inspections ensuring successful outcome, assist in compiling a response to inspection findings and timely execution of associated actions
- Qualification and quality oversight of business partners/distributors responsible for product in Switzerland
- Quality support to the commercial team for Switzerland, ensuring the affiliate is compliant and quality objectives are aligned
- Oversight of quality activities related to product launch and distribution activities conducted in the Swiss market
- Completion/oversight of product releases
- Participating in Internal Audits/Self-Inspections
- Ensuring appropriate Quality Technical Agreements are implemented in support of MAH, Affiliate and Supplier activities
- Relevant degree in a Scientific discipline
- Previous and recent direct experience as Quality Responsible Person (QRP) / Fachtechnisch Verantwortliche Person (FvP) is essential, minimum 5 years
- Technical know-how of manufacturing, import, wholesale activities including market release of pharmaceutical products: knowledge and experience of GMP and GDP
- A strong understanding of, and experience in quality management is essential
- Experience interfacing with regulatory bodies or working on regulatory submissions such as drafting of quality modules of the eCTD
- Ability to partner effectively with internal and external partners including experience with external third-party manufacturers, laboratories & distributors
- Analytical mind, ability to assess new products or new projects to define and implement the appropriate action plan for integration into the Horizon Quality System
- Customer orientated with excellent communication and interpersonal skills to interact at all levels including senior executives, contractors, and colleagues' skills and the ability to apply pragmatic logic to problem solving and issue resolution is also required
- Ability to travel internationally as required
This role requires good judgment and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills in English, German & Swissgerman. Be able to effectively lead a team located globally.
