Quality Manager
Location: Zürich, Switzerland
Duration: 18 months initial
Workload: 100% fulltime
Tasks:
* 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, and approve method validation/transfer protocols/reports, related SOPs, quality control plans, qualification protocols/reports, re-test protocols/reports of critical reagents for analytical methods, and regulatory relevant documents related to analytical methods.
* Coordinate and lead re-manufacturing of critical reagents for 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
Requirements:
* Degree in microbiology, pharmaceutical science, biotechnology, chemistry or closely related field with a minimum of 5 years experience within a QC laboratory or QA organization (with oversight of QC activities).
* A thorough understanding of pharmaceutical QM Systems 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.
* English is required, German beneficial
* Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred
* EU-Citizenship or valid Swiss Work Permit
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.