59 days ago on jobs.jnj.com

Head of Quality Assurance

Crucell Switzerland AG

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Head of Quality Assurance

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Head of Quality Assurance

Standorte:Bern, Schweiz
Quality Assurance
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Requisition ID: 000016LV

"Caring for the world... one person at a time”inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

Janssen Vaccines AG, a proud member of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide.

For our site in Berne we are looking for a highly committed

Head of Quality Assurance

The position will report directly into the Site Quality Head.

  • Leading the Quality Assurance department within the Quality Unit Bern
  • Act as deputy qualified person (stellvertretende Fachtechnich Verantwortliche Person)
  • Ensure that the needed capabilities with the QA group are available by coaching and developing the team members
  • Support operations, development and QC with cGMP guidance on all strategic decisions
  • Ensure compliance of products, processes, systems and equipment with global and local guidelines and procedures as well as with legal and regulatory requirements
  • Represent Quality in CMC reviews and approve CMC  sections for regulatory filing
  • Ensure budget adherence
  • Perform batch disposition for raw materials, intermediates and final products
  • Evaluate and approve deviation reports and ensure appropriate and effective CAPAs are defined and implemented
  • Define and measure the appropriate KPIs to manage the performance of the QC unit

  • University degree in natural sciences, medicine or pharmacy with at least 5 years working experience in a GMP regulated environment
  • Experience in quality assurance of biological or pharmaceutical products according to cGMP requirements
  • Knowledge of biological manufacturing processes
  • Experience in risk management
  • Strong leadership capabilities and communication skills
  • Experience working in a matrix organization and in an international environment
  • Strong strategic and conceptual skills, analytical thinking and problem-solving ability
  • Proactive attitude, challenging the status quo, decision maker
  • Team player, team builder
  • Experience in interacting with Health Authorities
  • Ability to simultaneously manage multiple projects, duties and assignments and prioritise accordingly
  • Very good verbal and written skills in English and German

We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms. Have we piqued your interest? Please send us your online application (CV, Working References etc.) – please click on apply.

Primärer Standort
Crucell Switzerland AG (8851)
Quality Assurance