Novartis Business Services GmbH
Site Quality Head(m/w/x)
Vollzeit
Senior
Keine Angabe
Nürnberg, Halle (Saale), Dresden, Leipzig
NO
Novartis Business Services GmbH25 Tage
Site Quality Head(m/w/x)
Vollzeit
Senior
Keine Angabe
Nürnberg, Halle (Saale), Dresden, Leipzig
Nejo KI-Zusammenfassung
In this role, you will lead quality assurance efforts, ensuring compliance with GxP and cGMP standards while guiding the Quality Assurance team. Your day-to-day responsibilities will include strategic planning, stakeholder coordination, and managing critical quality issues.
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Anforderungen
- •BS/MSc in Life Sciences or related experience
- •10 years of experience in GMP Pharmaceutical Manufacturing
- •At least 3 years in Quality Control and/or Quality Assurance
- •Proven track record in supporting Quality Control operations
- •In-depth knowledge of cGMP and FDA regulations
- •Ability to manage multiple projects with moderate complexity
- •Highly developed management and communication skills
- •Strong organizational and time management skills
- •Experience in process improvement approaches
Master-Abschluss
Berufserfahrung
10 Jahre
Deine Aufgaben
- •Provide leadership for strategic site initiatives
- •Represent site quality in local and global project teams
- •Support and direct the Quality Assurance department staff
- •Ensure staff are qualified, competent, and motivated
- •Create user requirements and specifications for projects
- •Coordinate with stakeholders for clear communication
- •Ensure facilities and equipment are safe and compliant
- •Oversee project planning, construction, and qualification
- •Maintain updated project plans to track progress
- •Escalate risks related to timelines and budgets
- •Manage product critical quality issues and deviations
- •Ensure effective execution of investigations and CAPAs
- •Define and monitor Site Quality KPIs
- •Establish and oversee the Site Quality Committee
- •Coordinate the execution of Site Quality Plans and assessments
- •Prepare and consolidate the Quality Unit budget
- •Ensure adherence to health and safety procedures
Tools & Technologien
Lean Six SigmaTotal Quality Management5S
Sprachen
Englisch – verhandlungssicher
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