Phadia GmbH
Laboratory Manager(m/w/x)
Vollzeitnur vor OrtSenior
Freiburg im Breisgau
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THThermo Fisher Scientific Inc.
Head of Quality Control and Process Care(m/w/x)
Freiburg im Breisgau
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Overseeing quality control testing for raw materials and finished goods, managing process care for IVD products. Leadership experience managing teams and ISO 13485/IVDR framework knowledge essential. Work impacting global health and safety.
Anforderungen
- Degree in natural, medical sciences, engineering, or equivalent
- Experience in diagnostics, immunoassays, ELISA, or IVD products
- Experience in Quality Control in regulated environments
- Leadership experience managing team leaders and teams
- Experience with ISO 13485 and IVDR frameworks
- Understanding of QC testing and goods release
- Knowledge of OOS, CAPA, and change control
- Knowledge of validation principles and method lifecycle
- Experience with audits and inspections
- Fluent German and English skills
- Strong IT skills, SAP and LIMS preferred
- Decision-making skills in regulated environments
- Ability to balance efficiency and compliance
- Business acumen and budget management experience
- Structured, risk-based problem-solving approach
- Stakeholder management and communication skills
- Experience in matrix and international organizations
- Change leadership and continuous improvement mindset
Aufgaben
- Lead quality control testing for raw materials and finished goods
- Improve analytical and immunological test methods
- Ensure routine testing readiness and data integrity
- Manage process care activities throughout the product lifecycle
- Oversee process validation and method lifecycle management
- Collaborate with R&D on product care and design transfers
- Approve quality-relevant validation within production interfaces
- Represent quality control in engineering and R&D projects
- Define routine testing and execute validation protocols
- Act as the technical interface for manufacturing and QA
- Support investigations using data-driven root cause analysis
- Lead and develop quality control and process care teams
- Manage cost center budgets and resource planning
- Drive continuous improvement in quality and compliance
- Support operational excellence and process scalability
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- ELISA
- ISO 13485
- IVDR
- SAP
- LIMS
Benefits
Betriebliche Altersvorsorge
- Company pension scheme
Sonstige Zulagen
- Fringe benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific Inc. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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THThermo Fisher Scientific Inc.
Head of Quality Control and Process Care(m/w/x)
Freiburg im Breisgau
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Overseeing quality control testing for raw materials and finished goods, managing process care for IVD products. Leadership experience managing teams and ISO 13485/IVDR framework knowledge essential. Work impacting global health and safety.
Anforderungen
- Degree in natural, medical sciences, engineering, or equivalent
- Experience in diagnostics, immunoassays, ELISA, or IVD products
- Experience in Quality Control in regulated environments
- Leadership experience managing team leaders and teams
- Experience with ISO 13485 and IVDR frameworks
- Understanding of QC testing and goods release
- Knowledge of OOS, CAPA, and change control
- Knowledge of validation principles and method lifecycle
- Experience with audits and inspections
- Fluent German and English skills
- Strong IT skills, SAP and LIMS preferred
- Decision-making skills in regulated environments
- Ability to balance efficiency and compliance
- Business acumen and budget management experience
- Structured, risk-based problem-solving approach
- Stakeholder management and communication skills
- Experience in matrix and international organizations
- Change leadership and continuous improvement mindset
Aufgaben
- Lead quality control testing for raw materials and finished goods
- Improve analytical and immunological test methods
- Ensure routine testing readiness and data integrity
- Manage process care activities throughout the product lifecycle
- Oversee process validation and method lifecycle management
- Collaborate with R&D on product care and design transfers
- Approve quality-relevant validation within production interfaces
- Represent quality control in engineering and R&D projects
- Define routine testing and execute validation protocols
- Act as the technical interface for manufacturing and QA
- Support investigations using data-driven root cause analysis
- Lead and develop quality control and process care teams
- Manage cost center budgets and resource planning
- Drive continuous improvement in quality and compliance
- Support operational excellence and process scalability
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- ELISA
- ISO 13485
- IVDR
- SAP
- LIMS
Benefits
Betriebliche Altersvorsorge
- Company pension scheme
Sonstige Zulagen
- Fringe benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific Inc. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Thermo Fisher Scientific Inc.
Branche
Science
Beschreibung
The company is a world leader in serving science, enabling customers to make the world healthier, cleaner, and safer.
Noch nicht perfekt?
- Phadia GmbH
Laboratory Manager(m/w/x)
Vollzeitnur vor OrtSeniorFreiburg im Breisgau - Thermo Fisher Scientific Inc.
Project Manager for Investment and Improvement Projects(m/w/x)
Vollzeitnur vor OrtSeniorFreiburg im Breisgau - Phadia GmbH
Wissenschaftler:in / Design Responsible(m/w/x)
Vollzeitnur vor OrtManagementFreiburg im Breisgau - providata GmbH
Leitung für unser Prozess- und Qualitätsmanagement(m/w/x)
Vollzeitnur vor OrtSeniorSchwerin, Freiburg im Breisgau - Alcon
Head of Customer Operations DACH(m/w/x)
Vollzeitnur vor OrtManagementFreiburg im Breisgau, Aschaffenburg