Senior Corporate Quality Manager
Vifor Pharma
St Gallen, Switzerland
vor 4 Tg.

About You

We are currently looking for a Senior Manager for Quality System and Issue Management to join our Corporate Quality Management (CQM) team located in St.

Gallen. You will ensure the quality compliance of the Quality Systems at Vifor Pharma Manufacturing sites, Affiliates, Distributors and Partners.

Your responsibilities will include :

  • Manage the Quality System processes
  • Assure quality compliance according to international GMP and GDP legal requirements in cooperation with international Vifor Pharma manufacturing sites and departments
  • Provide quality expertise and leadership for global and local quality activities
  • Support the first time, right approach in global Manufacturing, Quality and Distribution
  • Define, harmonise, maintain and continuously improve global quality processes and standards
  • Ensure that new or emerging GxP and regulatory changes are considered
  • Write, review and implement global and local SOPs
  • Manage issues, counterfeits and recalls
  • Support Third Party Management system
  • Define and implement corporate standards for the management of partners
  • Project Management of selected systems from the quality perspective
  • Evaluate product supply and release flows with regards to compliance and required contracts
  • Ensure the set-up, update and review of contracts (e.g. Distribution, Quality Agreements)
  • The successful candidate has a degree in a natural science field in addition to the following skills and experience :

  • Minimum of 5 8 years’ experience in a managerial role in the field of quality in the pharmaceutical industry
  • Understanding and knowledge of different quality systems approaches
  • Very high motivation, self-initiative, commitment and positive mindset
  • Very good knowledge of applicable legislations and guidelines for the pharmaceutical industry in general and country specific requirements
  • Work experience in different areas as Manufacturing (API, drug product, packaging), Supply Chain etc. would be beneficial
  • Knowledge of pharmaceutical quality systems, business processes and Quality IT-Systems (e.g. Quality Management Systems (e.
  • g. Trackwise), Document Management Systems)

  • Experience in conducting or receiving audits
  • 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 to take a risk based approach when addressing quality and compliance issues or gaps.

    You demonstrate high ethical standards, integrity and maintain confidentiality. You have strong stakeholder management, communication and change management skills and have a good intuition for people with the ability to convince with expertise and personality.

    You are able to understand, explain and simplify complex processes. Your proven experience in a similar position will allow you to be successful in this position and in line with Vifor Pharma values.

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