CSL

Manager, CMO Quality – EMEA

CSL

full-time

Posted on:

Location Type: Office

Location: St. Gallen • 🇨🇭 Switzerland

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Job Level

Mid-LevelSenior

About the role

  • Responsible for managing and supporting production efforts at CMOs and to provide quality oversight for outsourced operational activities.
  • Work on a regional basis (EMEA) with CMOs and cross-functional teams.
  • Develop and enforce Quality Agreements.
  • Support CMO Changes and Deviations, resolving quality issues and reviewing of Quality Performance KPI’s.
  • Provide on-site support at CMOs if needed.
  • Represent CSL Quality in operational meetings and projects.
  • Relationship management with key CMO partners is a core responsibility of this role.

Requirements

  • Requires a four-year degree in a relevant business or science, or equivalent education and experience.
  • Minimum of 5 years’ experience in a GxP environment in the pharmaceutical industry.
  • Thorough understanding of required regulations including but not limited to FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.
  • Strong industry and quality system knowledge (internal and external) experiences within the industry.
  • Must be comfortable working in a global, matrix organization.
  • Experience in CMO business highly preferred.
  • Strong organizational skills.
  • Fluent in English (written and spoken).
  • German knowledge is a plus.
Benefits
  • Health insurance
  • Application review assistance
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GxPQuality AgreementsQuality Performance KPICMO ChangesDeviationsQuality oversightRegulatory compliancePharmaceutical industry experienceQuality system knowledgeOperational support
Soft skills
Relationship managementOrganizational skillsCommunication skillsCross-functional collaborationProblem-solvingGlobal teamworkMatrix organization adaptability
Certifications
Four-year degree in business or science