Quality Manager.

  • Zürich, Zürich
  • veröffentlicht am 28. August 2024
  • läuft am 30. November 2024 ab
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Job Details

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Job Details
For our client, an international company in Zürich, we are looking for a Quality Manager.


General Information: 
  • Start date: ASAP/30.09.2024
  • End date: 31.03.2026
  • Extension: to be discussed
  • Workplace: Zürich
  • Home office: possible, hybrid role
  • Workload: 100%



Responsibilities:
 
  • Drive and support analytical method life cycle management (LCM) strategy for in-process, release and stability testing of commercial products
  • Leads multisite assay transfers via providing assay transfer strategy and project management with internal and external laboratories
  • Serve as SME for analytical methods incl biological, molecularbiological and microbiological methods established in the commercial release testing laboratories
  • Take ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.
  • Serve as in-house analytical / technical expert for troubleshooting and investigating laboratory issues
  • Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications
  • Represent Quality Control on technical product teams
  • Collaborate closely with in-house analytical / process technical expert for troubleshooting and investigating laboratory and manufacturing issues
  • Author/review/approve method validation/transfer protocols/reports and related SOP's
  • Coordinate and lead re-manufacturing of critical reagents for analytical methods
  • Author/review/approve quality control plans / qualification protocols/reports and re-test protocols/reports of critical reagents for analytical methods
  • Author/review/approve regulatory relevant documents related to analytical methods
  • Responsible for technical assessment of methods and changes to methods for compliance to GMP requirements, global Pharmacopeias, industry standards etc.
  • Create and enhance collaborative and trusting relationships with internal and external laboratories and internal SMEs and establish effective communication
  • Organize and lead cross functional team meetings with internal and external laboratories and SMEs



Your Profile:
 
  • Degree in microbiology, pharmaceutical science, biotechnology, chemistry or closely related field with a a minimum of 3 years experience within a QC laboratory or QA organization (with oversight of QC activities).
  • A thorough understanding of pharmaceuticyal QMSystems and respective guidelines and QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred.
  • Experience in vaccines and biologics manufacturing and testing and related guideline and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, preferred.
  • Strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses.
  • Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network.
  • Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to non-technical audience. Proven ability to clearly articulate technical issues concisely and deliver effective presentations on complex technical subjects
  • Ability to work in teams
  • English is required, German beneficial
  • Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred
For our client, an international company in Zürich, we are looking for a Quality Manager.


General Information: 
  • Start date: ASAP/30.09.2024
  • End date: 31.03.2026
  • Extension: to be discussed
  • Workplace: Zürich
  • Home office: possible, hybrid role
  • Workload: 100%



Responsibilities:
 
  • Drive and support analytical method life cycle management (LCM) strategy for in-process, release and stability testing of commercial products
  • Leads multisite assay transfers via providing assay transfer strategy and project management with internal and external laboratories
  • Serve as SME for analytical methods incl biological, molecularbiological and microbiological methods established in the commercial release testing laboratories
  • Take ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.
  • Serve as in-house analytical / technical expert for troubleshooting and investigating laboratory issues
  • Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications
  • Represent Quality Control on technical product teams
  • Collaborate closely with in-house analytical / process technical expert for troubleshooting and investigating laboratory and manufacturing issues
  • Author/review/approve method validation/transfer protocols/reports and related SOP's
  • Coordinate and lead re-manufacturing of critical reagents for analytical methods
  • Author/review/approve quality control plans / qualification protocols/reports and re-test protocols/reports of critical reagents for analytical methods
  • Author/review/approve regulatory relevant documents related to analytical methods
  • Responsible for technical assessment of methods and changes to methods for compliance to GMP requirements, global Pharmacopeias, industry standards etc.
  • Create and enhance collaborative and trusting relationships with internal and external laboratories and internal SMEs and establish effective communication
  • Organize and lead cross functional team meetings with internal and external laboratories and SMEs



Your Profile:
 
  • Degree in microbiology, pharmaceutical science, biotechnology, chemistry or closely related field with a a minimum of 3 years experience within a QC laboratory or QA organization (with oversight of QC activities).
  • A thorough understanding of pharmaceuticyal QMSystems and respective guidelines and QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred.
  • Experience in vaccines and biologics manufacturing and testing and related guideline and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, preferred.
  • Strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses.
  • Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network.
  • Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to non-technical audience. Proven ability to clearly articulate technical issues concisely and deliver effective presentations on complex technical subjects
  • Ability to work in teams
  • English is required, German beneficial
  • Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred

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LF

Laura Feig

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