We are currently looking for a Quality (Assurance) Manager to support the design and implementation of a new MES (Manufacturing Execution)-System at all Vifor Pharma manufacturing sites. This is a Corporate Quality role supporting the project team in a matrix organization. The position is located in St. Gallen and Zurich.
Vifor Pharma wants to support further business growth by handling the increasing complexity in the manufacturing and release process for ensuring a high quality and reliable supply of our innovative medicine to the patients to improve their lives. Therefore Vifor Pharma will take the next step by implementing a state of the art fully digitized and standardized manufacturing and release process solution in all 5 Vifor Pharma manufacturing sites. In this role, you will report to the Head of Corporate Quality End to End processes. You will have the chance to cover the quality aspects of this interesting project from the very beginning.
In a role focusing on manufacturing and release process, you will operate as the interface to Manufacturing, Quality (QA, QC), QPs and IT to jointly digitalize the batch records. You will overview all Vifor Pharma manufacturing and release site.
Your tasks can be described as follows:
- Support the design and implementation of the Manufacturing Execution System (MES, Software: Werum PAS-X) from the Quality Compliance perspective
- Understanding the as-is processes in the Vifor Pharma manufacturing sites
- Support the design of a harmonized, compliant and lean process for electronic (Master) Batch Records
- Visualization of processes
- Support the translation of this process in the MES-system and integrating other IT-systems and the underlying processes, e.g. LIMS, ERP
- Identify gaps between business and Quality needs and Technical/Functional Solutions and provide recommendations
- Support the roll-out of the MES-system to the different manufacturing sites
- Managing, maintaining and controlling the quality aspects of Werum PAS-X in the post go-live phase
- Identify and monitor the quality related project risks and initiate preventive and corrective actions
- Write, review or approve related manuals and procedures
- Support agency inspections and customer audits as needed
- Provide cross-company support for all Vifor Pharma site with regard to quality process optimization and operational excellence
- Build up the know-how to become the quality competence center for Manufacturing Execution System within Vifor Pharma
For this role you will bring the following education/experience:
- Bachelors or Master in a life science field (Chemistry, Pharmacy, other sciences, pharmaceutical engineer) or proven work experience in the pharmaceutical or related industries
- Ideally 1-3 years’ experience in operation function within the pharma industry or similar industry (i.e. food, medical devices)
- We would also consider a highly motivated graduate student giving a possibility to start in the pharmaceutical industry
understanding of manufacturing and release processes, either manually or electronical (Master) Batch Records, e.g. by involvement in (manual or electronic) batch record process in Manufacturing or QA
- Knowledge of laws and guidelines such as GMP, GDP, GAMP5, …
- Project management experience in process harmonization – optimization
- Ideally experience in the MES System (e.g. PAS-X by Werum (Germany))
- Demonstrated ability to successfully collaborate and negotiate across different sites, functions, cultures and management levels
- Ability to communicate clearly using all forms of communication across all forum
- Lean Six Sigma green or yellow belt certification would be an advantage
- Knowledge of IT system landscape within a manufacturing environment
- Fluent in English and German (written and verbally), French and Portuguese would be an asset
This position is based in St. Gallen and Zurich but you will collaborate across sites in Switzerland and Portugal.