64 days ago on jobs.jnj.com

Manager Inspections and Audits

Crucell Switzerland AG

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Manager Inspections and Audits

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Manager Inspections and Audits

Standorte:Bern, Schweiz
Funktion: Quality Assurance
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Requisition ID: 000016NO

"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

Manager Inspections and Audits(Ref. 0000XXX)

  • Responsibility for the internal audit program on site
  • Creation of a risk based annual schedule for internal audits
  • Conduct internal audits
  • Ensure that adequate and effective CAPAs are defined to address observations resulting from internal and external audits
  • Follow up of the timely implementation and effectiveness of CAPAs resulting from internal and external audits
  • Manage external inspection and audits from local and foreign Health Authorities, including the FDA, and customers
  • Responsibility for the response to reports from external inspection and audits
  • Manage audits from the corporate compliance including responding to the audit report
  • Oversight for remediation of observation addressed in external inspection and audits (including corporate audits)
  • Ensure that KPIs related to internal and external audits are green
  • Support Supplier Qualification in conducting audits at contract laboratories and suppliers
  • Liaise with other Johnson & Johnson companies in the Switzerland campus to facilitate an exchange of auditors and sharing of experiences

  • Master or Bachelor degree in pharmacy or a natural science
  • At least three years professional experience in a cGMP regulated environment, preferably in a Quality Assurance, Compliance or Manufacturing role
  • First leadership experience preferred
  • Good leadership capabilities and communication skills
  • Experience working in a matrix organization and in an international environment
  • Proactive attitude, challenging the status quo, team player, persistent
  • Ability to react on new situation and to quickly identify the essentials of an upcoming topic
  • 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.).

Primärer Standort
Crucell Switzerland AG (8851)
Quality Assurance