Location: Switzerland - St Gallen
Function: Quality Management
Company: Vifor Pharma
We are currently looking for a Quality ERP Champion (Manager) to join our Corporate Quality Management (CQM) team located in St. Gallen. In this role, you will report to the Head of Corporate Quality E2E processes and you will support the global team in designing and implementing the ERP-system. Your responsibilities will include:
- Support the overall Project Management Team in the planning and implementing of an ERP (Enterprise Resource Planning)-system (SAP S/4 HANA) for streamlining and harmonising the manufacturing-, release- and supply processes of medicinal products
- Ensuring the Quality compliance of the ERP-system and its interfaces to other IT-systems and the underlying processes
- QA role during the development, risk assessment, validation, implementation and maintenance of Quality relevant process workflows according to ERP project plan(s)
- Collaboration with quality team members and other process stream leaders to drive alignment and process standardisation
- Support the roll-out of the ERP-system to the different manufacturing sites
- Managing, maintaining and controlling the quality aspects of SAP S/4 in the post go-live phase
- Provide input of quality process design and integration with other systems and processes (e.g. LIMS)
- Identify and monitor the quality related project risks and initiate preventive and corrective actions
- Monitor that quality related business benefits included in the SAP/MES business case are delivered
- Conduct IT vendor, contractor and supplier audits
- Support the integration of the projects into the global IT landscape
- Presentation of the projects to the Steering Committees
- Write, review or approve related manuals and procedures
- Support agency inspections and customer audits as needed
- Coordination, planning and optimisation of resources and budget
The successful 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:
- Higher degree (Bachelors or Masters) in a technical field (Science, Business Administration, Engineering) or proven work experience
- 1-3 years’ experience in operation function within the pharma industry or similar industry (i.e. food, medical devices)
- Experience in Project Management
- Good understanding of laws and guidelines such as GMP, GDP, GAMP5
- In-depth understanding of business processes from launch of the production order to the final release
- Excellent change management skills
- Demonstrated ability to successfully collaborate and negotiate across different sites, functions and management levels
- Good knowledge of IT system landscape within a manufacturing and QC-environment
- Work experience in different areas as Manufacturing, Quality, Supply Chain, etc.
Knowledge of (pharmaceutical) quality systems, business processes and IT-Systems (e.g. LIMS)
- Experience with Operational Excellence and/or Business Process Management methodologies
- Experience with the harmonisation and simplification of business processes across multiple sites
- Experience with SAP planning system would be an advantage
- 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 later rolled-out to other Vifor Pharma manufacturing sites. Therefore an availability in St. Gallen for 2 to 3 days is required. For the other days there is the possibility to work also in Zurich.
You describe yourself as a self-confident person with strong organisational skills and the ability to take a risk based approach when addressing Quality and compliance issues or gaps. Demonstrating high ethical standards, integrity and maintenance of confidentiality, you prove to be able to lead Quality projects within timelines and budget until completion.
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.