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Site Quality Head(m/w/x)
Overseeing GxP/cGMP compliance for Radioligand Therapy (RLT) drug product manufacturing. 10+ years GMP Pharmaceutical Manufacturing experience required. Flexible working schedule, work from home option.
Anforderungen
- BS/MSc in Life Sciences or related experience
- 10+ years GMP Pharmaceutical Manufacturing experience
- 3 years Quality Control or Quality Assurance experience
- Experience supporting Quality Control operations units
- Compliance with global cGMP requirements
- In-depth knowledge of cGMP regulations
- Successful management of Health Authority inspections
- Ability to manage complex multiple projects
- Fluent written and spoken German
- Fluent written and spoken English
- Desirable experience with Health Authorities
Aufgaben
- Provide technical and strategic leadership for quality matters
- Ensure compliance with GxP and cGMP standards
- Oversee adherence to the company's Quality Manual
- Lead strategic site initiatives and cross-functional projects
- Verify safe and compliant facility and equipment installation
- Manage validation activities during project planning and construction
- Escalate risks regarding project timelines and budgets
- Oversee investigations into product quality deviations
- Define and analyze Site Quality KPIs
- Establish and manage the Site Quality Committee
- Coordinate Site Quality Plans and risk assessments
- Hire, develop, and retain a high-performing team
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- cGMP
Benefits
Attraktive Vergütung
- Competitive salary
Boni & Prämien
- Annual bonus
Flexibles Arbeiten
- Flexible working schedule
- Work from home possibility
Betriebliche Altersvorsorge
- Pension scheme
Sonstige Vorteile
- Employee Recognition Scheme
Gesundheits- & Fitnessangebote
- Expanded health promotion program
Sicherer Arbeitsplatz
- Employment at Top SI Employer
Weiterbildungsangebote
- Unlimited learning and development
Noch nicht perfekt?
- Novartis Radiopharmaceuticals GmbHVollzeitmit HomeofficeManagementHalle (Saale)
- Novartis Radiopharmaceuticals GmbH
Quality Assurance Officer Operations(m/w/x)
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Quality Assurance Officer Operations(m/w/x)
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Senior Quality & Process Manager(m/w/x)
Vollzeitmit HomeofficeSeniorKabelsketal - Novartis Radiopharmaceuticals GmbH
Process Expert(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenHalle (Saale)
Site Quality Head(m/w/x)
Overseeing GxP/cGMP compliance for Radioligand Therapy (RLT) drug product manufacturing. 10+ years GMP Pharmaceutical Manufacturing experience required. Flexible working schedule, work from home option.
Anforderungen
- BS/MSc in Life Sciences or related experience
- 10+ years GMP Pharmaceutical Manufacturing experience
- 3 years Quality Control or Quality Assurance experience
- Experience supporting Quality Control operations units
- Compliance with global cGMP requirements
- In-depth knowledge of cGMP regulations
- Successful management of Health Authority inspections
- Ability to manage complex multiple projects
- Fluent written and spoken German
- Fluent written and spoken English
- Desirable experience with Health Authorities
Aufgaben
- Provide technical and strategic leadership for quality matters
- Ensure compliance with GxP and cGMP standards
- Oversee adherence to the company's Quality Manual
- Lead strategic site initiatives and cross-functional projects
- Verify safe and compliant facility and equipment installation
- Manage validation activities during project planning and construction
- Escalate risks regarding project timelines and budgets
- Oversee investigations into product quality deviations
- Define and analyze Site Quality KPIs
- Establish and manage the Site Quality Committee
- Coordinate Site Quality Plans and risk assessments
- Hire, develop, and retain a high-performing team
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- cGMP
Benefits
Attraktive Vergütung
- Competitive salary
Boni & Prämien
- Annual bonus
Flexibles Arbeiten
- Flexible working schedule
- Work from home possibility
Betriebliche Altersvorsorge
- Pension scheme
Sonstige Vorteile
- Employee Recognition Scheme
Gesundheits- & Fitnessangebote
- Expanded health promotion program
Sicherer Arbeitsplatz
- Employment at Top SI Employer
Weiterbildungsangebote
- Unlimited learning and development
Über das Unternehmen
Novartis Radiopharmaceuticals GmbH
Branche
Pharmaceuticals
Beschreibung
Novartis Radiopharmaceuticals GmbH is a manufacturing plant for Radioligand Therapy (RLT) drug products.
Noch nicht perfekt?
- Novartis Radiopharmaceuticals GmbH
Site Quality Head(m/w/x)
Vollzeitmit HomeofficeManagementHalle (Saale) - Novartis Radiopharmaceuticals GmbH
Quality Assurance Officer Operations(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenHalle (Saale) - Novartis Radiopharmaceuticals GmbH
Quality Assurance Officer Operations(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenHalle (Saale) - JobRad GmbH Jobportal
Senior Quality & Process Manager(m/w/x)
Vollzeitmit HomeofficeSeniorKabelsketal - Novartis Radiopharmaceuticals GmbH
Process Expert(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenHalle (Saale)