Bavarian Nordic Berna GmbH
Quality Assurance Specialist Qualification(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Bern
CS
CSL BehringGestern
Associate Director, Quality Assurance Support(m/w/x)
Vollzeit
Senior
Keine Angabe
Bern
Nejo KI-Zusammenfassung
In this leadership role, you will drive operational excellence by overseeing complex quality management and cGMP compliance across the company's Bern site to ensure the delivery of life-saving therapies.
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Anforderungen
- •8+ years experience in similar role
- •High independence and self-directed learning
- •Knowledge of cGMP and Compliance
- •Engineering and maintenance operations expertise
- •Experience with utility monitoring programs
- •Material management, warehousing, and logistics
- •Quality control and analytical methods
- •Change control management skills
- •Deviation management skills
- •CAPA management skills
- •Strong collaboration and networking skills
- •Coaching and mentoring skills
- •Excellent communication and technical explanation
- •Strong influencing and presentation skills
Keine Angabe
Berufserfahrung
8 Jahre
Deine Aufgaben
- •Provide quality oversight for maintenance and utilities
- •Oversee quality control and warehouse operations
- •Manage qualification activities for operational and re-qualification projects
- •Ensure operational quality management follows cGMP standards
- •Review and approve complex GxP documentation
- •Support and approve quality risk assessments
- •Manage non-conformances, investigations, and CAPAs
- •Oversee complex change control processes
- •Monitor quality performance metrics to drive improvements
- •Lead complex cross-functional and global projects
- •Act as Subject Matter Expert during inspections
- •Collaborate with global quality assurance support functions
- •Drive quality decisions with diverse internal stakeholders
- •Conduct warehouse floor tours to address improvements
- •Implement new Quality on the Floor activities
- •Manage complex deviations at local and cross-site levels
- •Serve as Quality Delegate for change management
- •Review and complete raw material data for APR/PQR
- •Lead cross-functional Tier 1 operational meetings
- •Coordinate and deliver GMP training for new employees
- •Present quality investigations to health authorities
Tools & Technologien
cGMPUtility monitoring programsChange control managementDeviation managementCAPA management
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
Sonstige Vorteile
- •Reasonable accommodation for disabilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring 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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