Quality Manager
Vor 4 Tagen
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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, and approve method validation/transfer protocols/reports, related SOPs, quality control plans, qualification protocols/reports, and re-test protocols/reports of critical reagents for analytical methods, as well as 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 with GMP requirements, global Pharmacopeias, and industry standards.
- 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.
- Degree in microbiology, pharmaceutical science, biotechnology, chemistry, or a 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, as well as QC laboratory processes, is required; experience in an outsourced manufacturing and testing environment is preferred.
- Experience in vaccines and biologics manufacturing and testing, and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements is 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 is beneficial.
- EU-Citizenship or valid Swiss Work Permit is required.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
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