Quality Manager

TN Switzerland; Zürich; Vor Ort; CHF 80’000 - 120’000; Vollzeit

Zusammenfassung

An established industry player is seeking a skilled analytical expert to enhance their quality control processes. In this pivotal role, you will drive the analytical method life cycle management for commercial products, ensuring compliance with GMP requirements and industry standards. Collaborating with cross-functional teams, you will lead assay transfers and serve as a technical expert in troubleshooting laboratory issues. Your expertise in microbiology and statistical analysis will be key to resolving complex analytical challenges. Join a forward-thinking organization that values innovation and quality in pharmaceutical development, and make a significant impact in the field of quality assurance.

Qualifikationen

• Minimum 5 years experience in QC laboratory or QA organization.
• Thorough understanding of pharmaceutical QM Systems and QC processes.

Aufgaben

• Drive analytical method life cycle management for commercial products.
• Lead multisite assay transfers and provide project management.

Kenntnisse

Analytical Method Development

Statistical Analysis

Troubleshooting

Microbiology

Project Management

Collaboration

Ausbildung

Degree in Microbiology

Degree in Pharmaceutical Science

Degree in Biotechnology

Degree in Chemistry

Jobbeschreibung

• 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 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 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 guidelines 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.