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Senior Manager Device and Incoming Testing(m/w/x)
Supervising laboratory personnel for device and incoming goods testing of commercial pharmaceutical products at a global pharmaceutical company. 5-10 years regulated QC experience, Head of Quality Control qualification, and LIMS/LES systems experience required. Excellent company pension plan, access to Corporate University for continuous learning.
Anforderungen
- Master's degree or Bachelor's with extensive practical experience in GMP, management science related field
- Sufficient qualification for Head of Quality Control
- Minimum of 5-10 years of regulated industry experience in QC
- Experience with Devices and Incoming goods testing
- Previous experience with Laboratory IT systems such as LIMS and LES
- People management
- Fluent written and oral skills in German and English
- Participation in Regulatory inspections such as EMA, FDA
- Management experience of third-party laboratories
- Demonstrated knowledge and application of regulations applicable to the pharmaceutical industry and related quality systems
- Ability to mentor / train others, share learning
- Ability to travel (approximately 10-20 %)
Aufgaben
- Manage device testing and incoming goods testing activities
- Maintain a safe work environment and lead safety initiatives
- Ensure compliance with cGMP procedures and Quality Systems
- Supervise laboratory personnel and set performance standards
- Perform laboratory device testing for commercial products
- Manage incoming goods testing for commercial products
- Conduct method transfer, verification, and validation
- Participate in flow and process teams for collaboration
- Handle change management and deviation management
- Conduct laboratory investigations
- Organize the lab according to the 5S principle
- Ensure proper training for all analysts and technicians
- Build and maintain relationships with testing labs across the network
- Oversee QC laboratory equipment setup and qualification
- Support regulatory submissions and inspections
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- 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
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- 350 Lilly Deutschland GmbHVollzeitnur vor OrtSeniorAlzey
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Senior Manager Device and Incoming Testing(m/w/x)
Supervising laboratory personnel for device and incoming goods testing of commercial pharmaceutical products at a global pharmaceutical company. 5-10 years regulated QC experience, Head of Quality Control qualification, and LIMS/LES systems experience required. Excellent company pension plan, access to Corporate University for continuous learning.
Anforderungen
- Master's degree or Bachelor's with extensive practical experience in GMP, management science related field
- Sufficient qualification for Head of Quality Control
- Minimum of 5-10 years of regulated industry experience in QC
- Experience with Devices and Incoming goods testing
- Previous experience with Laboratory IT systems such as LIMS and LES
- People management
- Fluent written and oral skills in German and English
- Participation in Regulatory inspections such as EMA, FDA
- Management experience of third-party laboratories
- Demonstrated knowledge and application of regulations applicable to the pharmaceutical industry and related quality systems
- Ability to mentor / train others, share learning
- Ability to travel (approximately 10-20 %)
Aufgaben
- Manage device testing and incoming goods testing activities
- Maintain a safe work environment and lead safety initiatives
- Ensure compliance with cGMP procedures and Quality Systems
- Supervise laboratory personnel and set performance standards
- Perform laboratory device testing for commercial products
- Manage incoming goods testing for commercial products
- Conduct method transfer, verification, and validation
- Participate in flow and process teams for collaboration
- Handle change management and deviation management
- Conduct laboratory investigations
- Organize the lab according to the 5S principle
- Ensure proper training for all analysts and technicians
- Build and maintain relationships with testing labs across the network
- Oversee QC laboratory equipment setup and qualification
- Support regulatory submissions and inspections
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- 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
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.
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