For our customer located in Zurich/Switzerland we are currently looking for a Quality Manager (m/f/d).
Location: Zurich / Hybrid
Tasks & Responsibilities
* Drive and support analytical method life cycle management (LCM) strategy for in-process, release and stability testing of commercial products.
* Lead multisite assay transfers by providing assay transfer strategy and project management with internal and external laboratories.
* Serve as SME for analytical methods including biological, molecular biological, 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 experts for troubleshooting and investigating laboratory and manufacturing issues.
* Author/review/approve method validation/transfer protocols/reports and related SOPs.
* 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 with 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.
Must Haves
* Degree in microbiology, pharmaceutical science, biotechnology, chemistry, or closely related field with a minimum of 3 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.
* 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 a non-technical audience. Proven ability to clearly articulate technical issues concisely and deliver effective presentations on complex technical subjects.
* Ability to work in teams.
* Fluent in English.
* Six Sigma Lean Laboratory (Greenbelt or Blackbelt Certification preferred).
Nice to Haves
* Experience in an outsourced manufacturing and testing environment.
* Experience in vaccines and biologics manufacturing and testing and related guidelines and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements.
* Fluent in German.
Did we catch your interest?
The SimplyVision-Team is looking forward to receiving your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore, only applications from candidates within the EU or candidates holding Swiss work permission are required.
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