350 Lilly Deutschland GmbH
Senior Manager Device and Incoming Testing(m/w/x)
Vollzeitnur vor OrtSenior
Alzey
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35350 Lilly Deutschland GmbH
Senior Manager Chemical Testing(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading chemical testing for pharmaceutical batch release, ensuring data integrity with HPLC, UV-Vis, Empower, and LIMS. 5-10 years regulated QC industry experience, with Head of Quality Control qualification, essential. Excellent company pension, access to Corporate Lilly University.
Anforderungen
- Master’s degree or Bachelor in Analytical Chemistry, Chemistry, or Biology with extensive practical experience in GMP related field
- Sufficient qualification for Head of Quality Control
- Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
- Hands-on and management experience in chemical testing and relevant method validation/transfer per ICH guideline, including HPLC and UV-Vis
- Experience in working with Empower, LIMS and LES, ideally also in LIMS introduction
- People management
- Written and oral skills in German and English
- Participation in regulatory inspections such as EMA, FDA, etc.
- Management experience of third-party laboratories
Aufgaben
- Ensure timely completion of work to support batch release and site priorities
- Adhere to Environmental Health and Safety (EHS) requirements and laboratory safety procedures
- Maintain cleanliness and contamination control in line with cGMPs and biosafety guidelines
- Lead compliance activities with standard operating procedures (SOPs) and regulatory guidelines
- Ensure data integrity in accordance with ALCOA+ principles
- Manage data review to ensure accuracy and compliance
- Identify and escalate atypical results and potential deviations
- Participate in root cause analysis for laboratory investigations
- Implement corrective and preventive actions as required
- Communicate opportunities for continuous improvement
- Participate in cross-functional teams as needed
- Maintain training competencies and execute work only when qualified
- Participate in training and mentorship as requested
- Support audit readiness and participate in pre-inspection reviews
- Oversee and coordinate QC Chemical Testing activities to meet production needs
- Proactively manage workload for on-time delivery
- Engage with QC personnel to monitor activities and resolve issues
- Adjust resources to maintain smooth QC operations
- Address atypical results and operational problems directly with personnel
- Supervise the Chemical Testing team and set clear objectives
- Monitor team performance and provide ongoing coaching and feedback
- Conduct regular one-on-one check-ins with team members
- Recognize high performance and handle employee relations issues fairly
- Serve as the liaison between QC and other site functions
- Share and adopt best practices to drive operational excellence
- Ensure QC area is ready for inspection and address compliance gaps
- Manage laboratory costs and approve invoices as requested
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- HPLC
- UV-Vis
- Empower
- LIMS
- LES
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Weiterbildungsangebote
- Access to Corporate Lilly University
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland GmbH 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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35350 Lilly Deutschland GmbH
Senior Manager Chemical Testing(m/w/x)
Alzey
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading chemical testing for pharmaceutical batch release, ensuring data integrity with HPLC, UV-Vis, Empower, and LIMS. 5-10 years regulated QC industry experience, with Head of Quality Control qualification, essential. Excellent company pension, access to Corporate Lilly University.
Anforderungen
- Master’s degree or Bachelor in Analytical Chemistry, Chemistry, or Biology with extensive practical experience in GMP related field
- Sufficient qualification for Head of Quality Control
- Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
- Hands-on and management experience in chemical testing and relevant method validation/transfer per ICH guideline, including HPLC and UV-Vis
- Experience in working with Empower, LIMS and LES, ideally also in LIMS introduction
- People management
- Written and oral skills in German and English
- Participation in regulatory inspections such as EMA, FDA, etc.
- Management experience of third-party laboratories
Aufgaben
- Ensure timely completion of work to support batch release and site priorities
- Adhere to Environmental Health and Safety (EHS) requirements and laboratory safety procedures
- Maintain cleanliness and contamination control in line with cGMPs and biosafety guidelines
- Lead compliance activities with standard operating procedures (SOPs) and regulatory guidelines
- Ensure data integrity in accordance with ALCOA+ principles
- Manage data review to ensure accuracy and compliance
- Identify and escalate atypical results and potential deviations
- Participate in root cause analysis for laboratory investigations
- Implement corrective and preventive actions as required
- Communicate opportunities for continuous improvement
- Participate in cross-functional teams as needed
- Maintain training competencies and execute work only when qualified
- Participate in training and mentorship as requested
- Support audit readiness and participate in pre-inspection reviews
- Oversee and coordinate QC Chemical Testing activities to meet production needs
- Proactively manage workload for on-time delivery
- Engage with QC personnel to monitor activities and resolve issues
- Adjust resources to maintain smooth QC operations
- Address atypical results and operational problems directly with personnel
- Supervise the Chemical Testing team and set clear objectives
- Monitor team performance and provide ongoing coaching and feedback
- Conduct regular one-on-one check-ins with team members
- Recognize high performance and handle employee relations issues fairly
- Serve as the liaison between QC and other site functions
- Share and adopt best practices to drive operational excellence
- Ensure QC area is ready for inspection and address compliance gaps
- Manage laboratory costs and approve invoices as requested
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- HPLC
- UV-Vis
- Empower
- LIMS
- LES
Benefits
Betriebliche Altersvorsorge
- Excellent company pension plan
Sonstige Vorteile
- Individual benefits
Karriere- und Weiterentwicklung
- Career development opportunities
Weiterbildungsangebote
- Access to Corporate Lilly University
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 350 Lilly Deutschland GmbH 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
350 Lilly Deutschland GmbH
Branche
Healthcare
Beschreibung
The company is a global healthcare leader dedicated to discovering and bringing life-changing medicines to those in need.
Noch nicht perfekt?
- 350 Lilly Deutschland GmbH
Senior Manager Device and Incoming Testing(m/w/x)
Vollzeitnur vor OrtSeniorAlzey - 350 Lilly Deutschland GmbH
Senior Manager - Quality Control Environmental Monitoring(m/w/x)
Vollzeitnur vor OrtManagementWiesbaden, Alzey - 350 Lilly Deutschland GmbH
Senior Manager Microbiology Laboratory(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Principal Scientist - Quality Control Chemical Testing Lab(m/w/x)
Vollzeitnur vor OrtManagementAlzey - 350 Lilly Deutschland GmbH
Responsible Scientist – QC Microbiology Lab(m/w/x)
Vollzeitnur vor OrtSeniorAlzey, Wiesbaden