Head of Clinical Quality Management – Zurich

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Quality Management

Compagnie: Vifor Pharma

Georgia Izzat

International Talent Acquisition Specialist

+41 58 851 83 78

Conditions pour les agences de placement

Votre profil

In this strategic position, supporting our global quality organization, we are seeking a Head of Clinical Quality Management. You will be responsible to manage a team, implement processes related to the Vifor Pharma quality management goals and support with the development of clinical and regulatory strategies. Reporting directly to the Head of Global Quality Management, your tasks and responsibilities will include, but not be limited to, the following:
  • Manage staff respecting internal and external regulations and requirements
  • Establish and coordinate all audit programs for Quality Management (QM) Clinical, Medical and Regulatory
  • Provide Clinical Quality Assurance (CQA) expert input to business and projects
  • Ensure inspection readiness for Vifor Pharma organisations under CMR surveillance responsibility
  • Provide input, support and surveillance of Pharmacovigilance organisation/s within Vifor Pharma
  • Assure adequate CAPA management overview
  • Follow up and input into the organisation of guidance development
  • Assure CQA input in clinical development programs as well as timely audits of study sites and databases (GCP audits)
  • Support and survey affiliates in Agency Inspection preparation, management and subsequent CAPA implementation
  • Preparation, hosting and follow-up of Agency Inspections
  • Assures qualification of third party service providers
  • Track expenditures against approved budgets and establish plans within the planning cycles
  • Maintain procedural documents system and respective processes
  • Ensure adequate training status of CMR departments
  • Provide input into Corporate Quality Systems (Quality Risk Management, KPI etc.)
  • Ensure harmonisation of processes/PDs across locations & with QM GMP
The ideal candidate holds a university degree in life sciences field in addition to the following experience:
  • 5 – 10 years’ experience successful leading a Clinical Quality organisation, including managerial experience
  • GCP & PV experience in the pharmaceutical industry
  • Extensive understanding of interpretation for FDA, EU and ICH regulations (GCP, PV)
  • Demonstrated ability to develop, implement, maintain and improve quality organisations and procedures
  • Demonstrated ability to lead successfully different cultures
  • Successful collaboration with functions in the clinical, regulatory and quality area
  • Mandatory language skills in English and preferably German
  • Ability to use IT support systems in the office and QM – related area
You have excellent leadership, management and organisation skills. You have a compliance and solution driven style of communication and interaction with relevant stakeholders. You are able to work successfully independently and within a cross-functional environment. You practice high ethical standards, integrity and are able to maintain confidentiality. You are able to translate non-compliance into risk assessment. You effectively apply professional judgement on risks. You are precise in your working style. You work in line with the Vifor Pharma values.

A propos de nous

Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.

Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.

Pour plus d’informations, veuillez consulter notre site: http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.

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Conditions pour les agences de placement