Regional Quality Oversight Manager EMEA for Global Pharmaceutical Company

vor 18 Stunden


Bern, Bern, Schweiz CSL Behring Vollzeit

CSL Behring is seeking a highly skilled Regional Quality Oversight Manager to join our team in EMEA. This role will be responsible for managing and supporting production efforts at Contract Manufacturing Organizations (CMOs) and providing quality oversight for outsourced operational activities.

The successful candidate will have a strong understanding of required regulations including but not limited to FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc. They will also have experience in CMO business and be comfortable working in a global, matrix organization.

This is an excellent opportunity for a talented professional to make a meaningful impact on the quality of our products and services. If you are passionate about quality and have a drive to succeed, we encourage you to apply.

We offer a competitive salary of $120,000 - $150,000 per annum, depending on experience, as well as a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

About the Role

This role will be responsible for:

  • Developing and enforcing Quality Agreements with CMOs
  • Supporting CMO Changes and Deviations
  • Resolving quality issues and reviewing Quality Performance KPI's
  • Representing CSL Quality in Operational/Pre-Campaign Meetings
  • Collaborating with cross-functional teams to assure CMO Commercial Readiness (Tech Transfer) and CMO Operations
Key Responsibilities
  • Interface: Establish Collaborative Relationship with CMO and CSL MAH stakeholders (CMO Operations, Supply Chain, MAH Batch Release/QP)
  • Quality Contract: CMO Quality Agreements
  • Performance: Oversee, track and report on regional CMO quality performance
  • Escalation: Escalate Quality issues during Joint Operation Meetings
  • Standardization: Maintain standardized Quality Oversight processes with CMO and CSL Sites
  • Quality Representative: Represents QA in cross-functional project teams such as CMO Operations, commercial readiness, and process improvements


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