CMO Management Oral Products

Lieu: Switzerland - St Gallen

Fonction: Quality

Votre profil

An exciting newly, created role at Vifor Pharma has arisen for a Quality Professional for CMO Organizational Management to manage strategic supplier CMO relationships for oral products. Based in Fribourg or Lisbon. In this truly global role you will ensure the compliance of the Quality Systems of Vifor Third Parties.

You will be the primary internal owner of these relationships in conjunction with the team and work with both internal and external stakeholders to maximize efficacy and quality of products and processes related to external manufacturing of oral drug products.

Being a strong natural communicator and problem solver is essential as is taking a risk based but collaborative approach when approaching quality and compliance systems. Leading high value time critical projects on budget will be essential. High ethical standards and aligned values with the Vifor brand will be essential to ensuring that key medicinal products reach our patient communities swiftly and safely. Ideally you will have a leadership focus and enjoy building capabilities in this role which has direct reports.

Responsibilities

  • Managing the Quality System processes in relation to Third Parties
  • Assuring quality compliance of Third Parties acc. GMP requirements acc. the valid dossiers
  • Manage CMO and Suppliers with defined and agreed KPI’s with respect to quality, compliance, supply security, performance etc.
  • Problem solving, root cause analysis & continuous improvement activities with internal and external parties
  • Providing Quality expertise and leadership
  • Supporting the first time right approach in global Manufacturing, Quality and Distribution
  • Cooperation and timely and functional communication with internal and external stakeholders
  • Working cross functionally with various teams in the organisation
  • Managing issues and recalls in close cooperation with internal teams and CMOs
  • Ensuring implementation of new products in CMOs with analytical transfers, supporting technical transfer etc.
  • Definition and implementation of corporate standards for the management of Third Parties
  • Ensuring setting-up, updating and reviewing of Quality Agreements
  • Building up and developing a strong motivated team at different sites

Experience and Qualifications

  • Higher degree (Bachelors or Masters) in a natural science field or extended experience in comparable functions
  • Min. 5 – 8 years management experience in the field of quality in the pharmaceutical industry
  • Very high motivation, self-initiative, commitment and positive mindset
  • Strong stakeholder management, communication and change management skills and contacts to an extended network
  • Good intuition for people and ability to convince with expertise and personality
  • Process thinking, ability to understand, explain and simplify complex processes
  • Strong Operational Excellence expertise with proven track record in solving problems
  • Very good knowledge of applicable legislations and guidelines for the pharmaceutical industry
  • Work experience in different areas as Manufacturing (API, drug product, packaging), Supply Chain etc. would be beneficial
  • Knowledge of pharmaceutical quality systems
  • Experience in conducting or receiving audits
  • Fluency in English (both spoken and written) and ideally advanced level in German. Knowledge of French or Portuguese would be an advantage

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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