Location: Switzerland - St Gallen
Function: Quality Management
Company: Vifor Pharma
We are currently looking for a Quality (Assurance) Manager to support a new ERP (Enterprise Resource Planning) solution in the Vifor Pharma manufacturing sites.
This is a Corporate Quality Compliance role in a matrix organisation. The position is located in St. Gallen and Zurich.
Vifor Pharma wants to support further business growth by ensuring a high quality and reliable supply of our innovative medicine to patients to improve their life. Therefore Vifor Pharma will take the next step by implementing a state of the art digitised and standardised supply chain management solution in the 5 manufacturing sites. In this role, you will report to the Head of Corporate Quality E2E processes. You will have the chance to support this interesting project from the very beginning.
Your responsibilities will include:
- Support the overall Global Project Team in the planning and implementation of an ERP (Enterprise Resource Planning)-system (SAP S/4 HANA & IBP)
- Understanding the as-is processes in the Vifor Pharma manufacturing sites
- Support the design of a harmonised, compliant and lean process from ordering to supply (E2E-process)
- Visualisation of these processes
- Support the translation of this process in the ERP-system and integrating other IT-systems and the underlying processes, e.g. LIMS
- Identify gaps between business and Quality needs and Technical/Functional Solutions and provide recommendations
- Support the roll-out of the ERP-system to the different manufacturing sites and supply network
- Managing, maintaining and controlling the quality aspects of SAP S/4 in the post go-live phase
- Identify and monitor the quality related project risks and initiate preventive and corrective actions
- Presentation of the projects to the Quality team leadership
- Write, review or approve related manuals and procedures
- Support agency inspections and customer audits as needed
The ideal candidate needs to have strong communication skills and the ability to work successfully across different sites, functions and management levels, and will bring the following profile:
- Bachelors or Master in a life science field (Chemistry, Pharmacy, other sciences, pharmaceutical engineer) or proven work experience in the pharmaceutical or related industries
- 1-3 years’ experience in operation function within the pharma industry or similar industry (i.e. food, medical devices)
- We would also consider giving a motivated graduate student the possibility to start
- Experience in Project Management
- Knowledge of laws and guidelines such as GMP and GDP
- Understanding of business processes from ordering to manufacturing to final delivery
- Apply knowledge of Change Control, Product Structure, Specification Management, Document Control, Quality Manufacturing, processes in a Life Sciences/Pharma/ Biotech/Process Industry company
- Ability for collaborating across different sites, functions, management levels and cultures
- Knowledge of the (Quality-)IT system landscape within a supply chain, manufacturing and QC-environment, such as ERP-systems, LIMS etc.
- Work experience in different areas such as Manufacturing, Quality, Supply Chain, etc.
- Experience with Operational Excellence and/or Business Process Management methodologies
- Experience with harmonisation and simplification of business processes across multiple sites
- Experience with SAP planning systems would be an advantage
- Ability to communicate clearly using all forms of communication across all forum
- Lean Six Sigma green or yellow belt certification would be an advantage
- Fluency in English and German (both spoken and written)
- Knowledge of French would be an advantage
- Availability to travel
The pilot project will start in St. Gallen and will later be rolled-out to other Vifor Pharma manufacturing sites. Therefore an availability in St. Gallen for 2 to 3 days per week is required. For the other days there is the possibility to also work in Zurich.
You describe yourself as a self-confident person with strong organisational skills. Demonstrating high ethical standards, integrity and maintenance of confidentiality, you prove to be able to support projects with high quality and enthusiasm.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.