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Director Quality(m/w/x)
Ensuring GMP compliance for drug delivery forms at global manufacturer with 7,000+ products, leading a 100-person team. Degree in Pharmacy, Chemistry, or Biology, plus pharmaceutical regulatory compliance and management experience required. Application support for disability.
Anforderungen
- Degree in Pharmacy, Chemistry, or Biology
- Experience in pharmaceutical quality management
- Knowledge of GMP regulations and standards
- Experience in managing audits and inspections
- Understanding of pharmaceutical manufacturing processes
- Excellent leadership and people management skills
- Strategic thinking and problem-solving ability
- Strong communication in German and English
- High integrity and compliance orientation
- Ability to manage complex projects
- Strong customer focus and advisory skills
- Familiarity with digital quality systems
Aufgaben
- Lead a quality organization of nearly 100 employees
- Prioritize patient safety and product quality in all decisions
- Select, manage, and evaluate departmental staff
- Ensure compliance with international GMP and legal requirements
- Implement global quality policies into local processes
- Advise customers on quality-related matters and service
- Align departmental tasks with corporate economic objectives
- Meet annual operational revenue and performance targets
- Oversee testing of raw materials and finished pharmaceuticals
- Support process and cleaning validations with analytical data
- Prepare master orders and manufacturing documents
- Manage the release of bulk and finished products
- Coordinate regulatory, customer, and supplier audits
- Conduct internal self-inspections and quality audits
- Manage complaints, deviations, and regulatory matters
- Maintain a quality reporting system for process improvement
- Oversee computer validation and equipment qualification
- Manage SOP systems and GMP training programs
- Optimize processes while maintaining legal compliance
- Share quality-related information across corporate sites
- Execute special projects assigned by leadership
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- EU GMP
- AMWHV
- 21 CFR 210/211
- Digital quality systems
- Process optimization tools
Benefits
Karriere- und Weiterentwicklung
- Karrieremöglichkeiten
Sonstige Vorteile
- Bewerbungsunterstützung bei Behinderung
Noch nicht perfekt?
- CatalentVollzeitnur vor OrtSeniorEberbach
- Catalent, Inc.
Teamleiter pharmazeutische Produktion(m/w/x)
Vollzeitnur vor OrtSeniorEberbach - Lamm HR GmbH
Mitarbeiter Qualitätskontrolle(m/w/x)
Vollzeitnur vor OrtKeine AngabeFriedrichsdorf - Catalent, Inc.
Head of Environmental, Health & Safety(m/w/x)
Vollzeitnur vor OrtSeniorEberbach - Catalent, Inc.
IT Service Delivery Site Manager(m/w/x)
Vollzeitnur vor OrtSeniorEberbach
Director Quality(m/w/x)
Ensuring GMP compliance for drug delivery forms at global manufacturer with 7,000+ products, leading a 100-person team. Degree in Pharmacy, Chemistry, or Biology, plus pharmaceutical regulatory compliance and management experience required. Application support for disability.
Anforderungen
- Degree in Pharmacy, Chemistry, or Biology
- Experience in pharmaceutical quality management
- Knowledge of GMP regulations and standards
- Experience in managing audits and inspections
- Understanding of pharmaceutical manufacturing processes
- Excellent leadership and people management skills
- Strategic thinking and problem-solving ability
- Strong communication in German and English
- High integrity and compliance orientation
- Ability to manage complex projects
- Strong customer focus and advisory skills
- Familiarity with digital quality systems
Aufgaben
- Lead a quality organization of nearly 100 employees
- Prioritize patient safety and product quality in all decisions
- Select, manage, and evaluate departmental staff
- Ensure compliance with international GMP and legal requirements
- Implement global quality policies into local processes
- Advise customers on quality-related matters and service
- Align departmental tasks with corporate economic objectives
- Meet annual operational revenue and performance targets
- Oversee testing of raw materials and finished pharmaceuticals
- Support process and cleaning validations with analytical data
- Prepare master orders and manufacturing documents
- Manage the release of bulk and finished products
- Coordinate regulatory, customer, and supplier audits
- Conduct internal self-inspections and quality audits
- Manage complaints, deviations, and regulatory matters
- Maintain a quality reporting system for process improvement
- Oversee computer validation and equipment qualification
- Manage SOP systems and GMP training programs
- Optimize processes while maintaining legal compliance
- Share quality-related information across corporate sites
- Execute special projects assigned by leadership
Berufserfahrung
- 5 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- EU GMP
- AMWHV
- 21 CFR 210/211
- Digital quality systems
- Process optimization tools
Benefits
Karriere- und Weiterentwicklung
- Karrieremöglichkeiten
Sonstige Vorteile
- Bewerbungsunterstützung bei Behinderung
Über das Unternehmen
Catalent
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Entwicklung von Darreichungsformen von Medikamenten und bietet über 7.000 Produkte an.
Noch nicht perfekt?
- Catalent
Head of Production - Finishing(m/w/x)
Vollzeitnur vor OrtSeniorEberbach - Catalent, Inc.
Teamleiter pharmazeutische Produktion(m/w/x)
Vollzeitnur vor OrtSeniorEberbach - Lamm HR GmbH
Mitarbeiter Qualitätskontrolle(m/w/x)
Vollzeitnur vor OrtKeine AngabeFriedrichsdorf - Catalent, Inc.
Head of Environmental, Health & Safety(m/w/x)
Vollzeitnur vor OrtSeniorEberbach - Catalent, Inc.
IT Service Delivery Site Manager(m/w/x)
Vollzeitnur vor OrtSeniorEberbach