HEAD OF CORPORATE QUALITY E2E PROCESSES - ST. GALLEN

Location: Switzerland - St Gallen

Function: Quality Management

Company: Vifor Pharma

Kira Maurer

Junior Talent Acquisition

+41 58 851 83 48

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About You

We are currently looking for a Head of Corporate Quality E2E processes to join our Corporate Quality Management (CQM) team located in St. Gallen. In this role, you will report to the Head of Corporate Quality Management and lead the group that is responsible for IT-systems ensuring Quality aspects in E2E-processes. Your and your group’s responsibilities will include:
  • Lead the Corporate Quality E2E-processes Group (up to 3 people)
  • Ensuring the Quality compliance for processes and used IT-systems
  • Support and manage corporate business process harmonisation and improvement activities for E2E-processes in Quality, Supply Chain and Manufacturing
  • Develop and lead the Vifor Pharma Corporate Archiving and Records Management program (define corporate standard and lead all related projects from a business and Quality perspective)
  • Support and guide the introduction of global IT-systems as e.g. Archiving, Records Management, ERP- and MES-systems from the Quality perspective
  • Quality Assurance (QA) role during the development, risk assessment, validation, implementation and maintenance of Quality relevant corporate IT-Systems and process workflows
  • Support of CSV-projects in the assigned role (Process Owner, QA Manager and/or Business Project Manager)
  • Act in the QA role during the operational phase of quality relevant IT systems along the entire system life cycle
  • Power User role of main Corporate Quality Management owned IT Systems (e.g. eDMS (Data Management Systems), eArchiving)
  • 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
  • Provide input during the global Quality audit planning cycles and execute internal and external Quality audits according to plan, e.g. IT vendor, suppliers
  • Support the development, implementation and maintenance of the Vifor Pharma Quality System
  • Provide input for the Quality KPI Report and implement performance improvements
  • 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 have the ability to work successfully across different sites, functions and management levels, and will bring the following profile:
  • Higher degree (Bachelor or Master) in a natural science field or practical experience in a related area
  • 5 – 8 years of experience in the Pharmaceutical, Medical Device Industry and/or similar Industry
  • Work experience in different areas as Manufacturing, Quality, Supply Chain, etc.
  • Knowledge of pharmaceutical quality systems, business processes and IT-Systems
  • Experience in the implementation of larger cross functionally used applications (e.g. ERP, MES)
  • Knowledge of applicable legislation, industry standards and norms within the area of GxP, process automation and GDPR
  • Experience in Data Classification and Records Management
  • Experience in the physical and electronic archiving of documents
  • Strong stakeholder management, communication and change management skills
  • Demonstrated ability to lead and manage cross-functional multi-site projects and programs at corporate level
  • Experience with Operational Excellence and/or Business Process Management methodologies as well as with the harmonisation and simplification of business processes across multiple sites
  • Work experience as lead or co-auditor
  • Experience as a line manager and/or project manager
  • Lean Six Sigma green or yellow belt certification would be an advantage
  • Fluency in English (both spoken and written) and advanced level in German
  • Knowledge of French would be an advantage
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. Finally, your proven experience in a similar position will allow you to be successful in this position and in line with Vifor Pharma values.

About Us

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.

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