BeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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BEBeOne Medicines I GmbH
Senior Manager, GCP Inspection Lead(m/w/x)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading GCP inspection readiness and serving as inspection lead for Health Authority inspections at a rapidly growing oncology biotech. 7+ years GCP QA experience in pharma/biotech required. Collaboration with cross-functional teams on inspection strategies and storyboard development.
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Anforderungen
- Basic Microsoft Office Programs
- 7+ years GCP-related Quality Assurance experience in pharmaceutical, biotechnology, or related health care industry
- High understanding of international GCP requirements and standards in pharmaceutical, medical device, and biotech industries
- Excellent English language skills
- Additional language skills depending on locations and need
- Excellent verbal and written communication skills
- Effective collaboration in a dynamic environment
- Flexibility to travel, including international
- Up to 35% travel, sometimes with short notice
Aufgaben
- Lead GCP inspection readiness activities
- Serve as inspection lead for Health Authority inspections
- Collaborate with cross-functional teams to develop inspection strategies
- Manage end-to-end inspection readiness activities
- Develop and maintain inspection storyboards with SMEs
- Identify and mitigate inspection-related risks
- Plan and lead mock inspections and Health Authority inspections
- Coordinate and assign inspection requests to SMEs
- Ensure accurate, timely, and effective inspection responses
- Create and revise SOPs for inspection readiness
- Implement and maintain QA systems
- Manage investigations, SQEs, deviations, and CAPAs
- Solve complex problems with in-depth evaluation
- Fulfill inspection commitments and post-inspection activities
- Manage a central repository of global inspection status
- Support Site Inspection Preparation Visits
- Lead post-inspection lessons learned sessions
- Drive sustainable process improvements
- Define strategic direction for quality systems
- Enhance inspection readiness and operational excellence
- Mentor and develop team members and cross-functional partners
- Understand global regulatory requirements for clinical trials
Berufserfahrung
7 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
other – verhandlungssicher
Englisch – verhandlungssicher
Tools & Technologien
Microsoft Office ProgramsGCP
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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.
Zur Originalanzeige bei BeOne Medicines I GmbHÜber das Unternehmen
BE
PharmaceuticalsBasel
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
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