270 days ago on vifor.avature.net

HEAD CORPORATE QUALITY MANAGEMENT - ST. GALLEN OR ZURICH

Vifor Pharma AG

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HEAD CORPORATE QUALITY MANAGEMENT - ST. GALLEN OR ZURICH

Ihr Profil

We are currently looking for a Head Corporate Quality Management (CQM) to join our global Quality Management team located in St. Gallen (you can be based either in St. Gallen or in Zurich). In this role you will report to the Head Global Quality Management and you will be responsible for planning and managing staff and financial resources within CQM. In addition your responsibilities include ensuring the execution of quality tasks and programs as well as implementing processes representing corporate and Vifor Pharma goals. Your tasks in this role include but are not limited to:

  • Manage resources respecting internal and external regulations/ requirements

    Ensure global audit planning, QAG management to maintain and improve supplier qualification (in collaboration with Quality Management organizations)

  • Provide CQM subject matter expertise to business and projects

  • Ensure inspection readiness

  • Support and monitor affiliates in Agency Inspection preparation as well as manage subsequent CAPA implementation

  • Track expenditures against approved budgets and establish plans within the planning cycles

  • Lead the development, implementation and maintenance of the VPQS, QRM and ensure Quality System Management Reviews

  • Coordinate and ensure compliance for Third Party Management

  • Establish and maintain periodic Quality metrics

  • Ensure harmonization of processes/ PDs across locations and Quality-Units

  • Develop and maintain a Quality IT Roadmap and IT systems where CQM is business owner

  • Ensure compliance for global IT systems

  • Manage and coordinate global issues, counterfeits and recalls

  • Collaborate with all stakeholders within and outside Quality Management

  • Represent Head Global Quality Management in his absence as deputy
The successful candidate has excellent leadership, management and organizations skills as well as a compliance and solution driven style of communication and interaction with all relevant stakeholders. Along with the ability to work successfully independently and in cross-functional teams, you will bring the following profile:
  • University degree in health sciences or related field

  • Several years successful lead of a Quality organization of a pharmaceutical entity

  • GMP/ GDP/ GCP and PV experience in the pharmaceutical industry

  • Extensive understanding of interpretation for FDA, EU and ICH regulations

  • Demonstrated ability to develop, implement, maintain and improve quality organizations and procedures

  • Demonstrated ability to lead successfully different cultures

  • Ability to translate non-compliance into risk assessments

  • Successful collaboration with functions in the clinical, regulatory and quality area

  • High ethical standards, integrity, maintenance of confidentiality

  • Fluent in English, German and French

  • Ability to use IT support systems in the office and Quality Management related area

  • Ability to drive improvement initiatives/ operational excellence in QA and QC


Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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