Quality Management NPI – St Gallen

Lieu: Switzerland - St Gallen

Fonction: Quality

Niveau de Séniorité: Manager

Votre profil

Vifor Pharma, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, is experiencing rapid growth due to pipeline realization and optimization.

We are currently looking for a Quality Management NPI for our St. Gallen location. In this exciting position, you will be reporting to the NPI / M&A Management.

Key Responsibilities
  • Identify and report Quality gaps and risks for new products/assets in integration phase
  • Establish remediation plan when possible
  • Support new assets integration into Vifor Pharma Quality System/Organization up to Operations
  • Represent Quality function in corresponding cross-functional teams
  • When required, support actively due diligence phase from a GxP compliance standpoint
Functional responsibilities
  • Lead implementation of new assets within Vifor Pharma Quality System
  • Represent Quality in Vifor Products Project Team
  • Ensure compliance until Market Launch for newly integrated assets, and provide the appropriate support during the handover to Operations
  • Manage deviations, OOS or findings during assets due diligence or integration
  • Establish corresponding Quality Agreements and other relevant quality documents
  • Supervise related Third-Party Audit
  • Advise Senior Management for compliance evaluation and remediation when needed
  • Support due diligence performed on assets from Quality standpoint
  • Financial competency according Vifor Pharma regulations
Hygiene and cleaning
  • Respect hygiene rules and dress codes
  • Ensure collaborators trainings on Health, Safety, Environment and Vifor compliance requirements
  • Adopt an exemplary behavior safety, health and environment aspects and reflect it in the individual objectives
  • Provide appropriate means for a correct application of the measures and check their correct application
  • Complies with Vifor quality procedures based on cGMP standards, including active participation in hygiene and good documentary practices
  • Immediately announces any breach of Vifor procedures
  • Faithfully reports on the situations encountered and identifies solutions where possible
  • Do not carry out cGMP activities without prior training
  • Travelling will be required for this position (5-10%)
Key Measures of Success
  • Project timelines for evaluation of new assets are fulfilled from a Quality Standpoint
  • Integration of new assets in Operations is done according to plans
  • Anticipate and escalate any major quality issue when it comes to product integration
  • Smooth interface with Vifor Quality Operations/Services/Assurance
  • Major/Critical quality risks are identified proactively, and mitigation plans proposed accordingly

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

Minimum Requirements
  • Master’s degree in Pharmaceutical sciences 
  • 7-10 years overall experience within Pharmaceutical and biotech industry
  • Previous roles in interaction with external customers (CMO environment) or management of multi-sites operations.
  • Familiar with product development up to commercial phase, manufacturing or technical transfer including analytical sections
  • CMC dossier knowledge
  • Good knowledge of Quality Systems and GxP
  • Proven track of record in Operations and Project Management
  • Fluent English language skills (German and/or French would be an asset)
Preferred Requirements
  • Exposed to international experience
  • Leadership position in matrix organization
  • Acting as a role model for others in terms of the Vifor Pharma Values and continuously display a positive can-do attitude with a focus on the customers’ needs.

A propos de nous

Le groupe Vifor Pharma est une entreprise pharmaceutique internationale spécialisée. Son ambition est de devenir le leader mondial dans les domaines de la carence en fer, de la néphrologie et des traitements cardio-rénaux. L’entreprise est le partenaire de choix pour les médicaments et les solutions innovantes axées sur le patient. Le groupe Vifor Pharma aspire à aider les patients du monde entier atteints de maladies graves et chroniques à mener une vie meilleure et plus saine. La société développe, fabrique et commercialise des produits pharmaceutiques offrant des soins de précision aux patients. Le groupe Vifor Pharma occupe une position de premier plan dans toutes ses activités clés. Il se compose des entreprises suivantes: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care); et OM Pharma.

Le groupe Vifor Pharma a son siège en Suisse et est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Pour de plus amples informations, veuillez consulter www.viforpharma.com/career

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