Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company committed to developing and commercializing
innovative medicines to meet the needs of patients living with rare and other diseases with high unmet medical needs.
At Santhera, our people are the driving force behind our success. Our collective loyalty, courage, and resilience set us
apart and help us thrive through change as a collaborative team. We create a purposeful workplace where your
contribution matters, growth is fostered, and together we make a real impact for those living with rare diseases and for
each other.
Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe
impact on the lives of affected children and adults. You can make a difference as:
Senior GVP QA Manager
Location: Pratteln, Switzerland (Hybrid)
Who you are
You are a collaborative and proactive quality professional with solid experience in pharmacovigilance and a strong
understanding of GVP compliance and quality systems. You enjoy working in dynamic environments where processes
and structures continue to evolve, and you are motivated by the opportunity to help build and strengthen scalable QA
oversight frameworks.
You bring a hands-on mindset combined with the ability to work strategically across multiple stakeholders, affiliates,
and external partners. You are comfortable navigating complexity, driving improvements, and ensuring high quality and
compliance standards in a growing international environment.
Scope of Work
The Senior GVP QA Manager is responsible for supporting the maintenance and continuous improvement of the global
Pharmacovigilance (PV) System to ensure that Santhera fulfils its legal PV obligations as both a Marketing
Authorisation Holder (MAH) and Sponsor of clinical trials.
The role supports PV oversight activities, process improvement initiatives, and compliance with applicable global
regulatory requirements.
Responsibilities include supporting the implementation and maintenance of PV procedures and the PV audit
programme, including the planning, coordination, execution, and follow-up of internal and external PV audits,
contributing to inspection readiness activities, and collaborating with in-ternal and external stakeholders to support
effective oversight and ongoing compliance of the PV System.
Key Responsibilities
- Assisting with the continuous review and improvement of Santhera’s PV System
- Ensuring timely release of new PV procedures, or updates of existing PV procedures, as needed.
