Votre profil
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.
We are currently looking for a Quality Assurance Manager /Specialist CMO/ Supplier Management Oral Products to join our team in St Gallen.
Main Responsibilities
- Management of CMOs and Suppliers for the oral portfolio.
- Processing all quality related tasks for the outsourced manufacturing and services to different contract manufacturing organizations (CMOs) for the oral portfolio (e.g. deviations, change controls, QAGs).
- Comply with the legislation applicable to the respective activities and with CSL Vifor procedures.
- Handling of complaints.
- Guarantee cGMP compliance by assuring that all products requirements are followed as agreed in the QAGs (Quality Agreements).
- Quality representative in CSL Vifor projects at CMOs for the oral portfolio.
- Manage and regularly evaluate data regarding the KPIs (Key Performance Indicators) established for the area.
- Able to operate compliant with applicable internal and external Quality requirements, by also bearing the business context in mind.
- Support achieving lean, effective, and efficient processes.
- Actively participate in the implementation of improvements in the department.
- Collaboration with internal and external stakeholders.
- Able to allocate own time and resources in a reasonable and efficient manner and in alignment with input from line manager.
Qualifications
Minimum Requirements
- Bachelor/Master’s Degree in Life Sciences or related industries or working experience in Pharm. Industry
- Minimum of 3-5 years overall experience within the pharmaceutical, biotechnology, or medical device industry
- Experience in Quality Assurance function
- Communication skills to negotiate and explain quality related topics with different external stakeholders and contract organizations
- Experience in troubleshooting and problem solving
- Good team player
- Fluency in English
Preferred Requirements
- Experience in lean management tools and Operational Excellence, Belt Certificate
- Working experience in different cultures
- Working experience in QC, Pharmaceutical/Analytical Development and/or Manufacturing
- Audit experience
- Other language skills as e.g., German, Portuguese, French