1201 F. Hoffmann-La Roche AG
QA Manager(m/w/x)
Vollzeitnur vor OrtSenior
Kaiseraugst
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
IDIdorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality oversight for small-molecule drug trials and CRO collaboration at biotech with 1,200+ employees. Extensive GCP auditing and health authority interaction experience required. 40-hour week, 25-30 days vacation.
Anforderungen
- Background in Good Clinical Practices
- Master’s degree in scientific discipline
- Knowledge in Quality Assurance and Auditing
- Industry or health authority experience
- Experience in GCP Quality Assurance
- Experience in Clinical Research & Development
- Understanding of ICH-GCP and regulations
- Experience with clinical electronic systems
- Experience in cross‑cultural environments
- Excellent communication skills
- Problem solving and risk management
- Negotiation and influencing capabilities
- Reliability, conscientiousness, and adaptability
- Independent and collaborative work ability
- Ability to travel
- Fluency in English
Aufgaben
- Act as the key quality partner for clinical trial teams
- Provide expert guidance during study planning, execution, and closure
- Ensure compliance with regulatory requirements and Good Clinical Practice
- Collaborate with internal teams and CROs to support trial conduct
- Resolve quality-related questions with internal and external partners
- Identify risks and propose pragmatic solutions
- Escalate significant quality issues when necessary
- Develop and deliver GCP and clinical quality training
- Optimize quality processes, tools, and clinical systems
- Lead health authority inspection preparation and follow-up
- Conduct audits of sites, vendors, and processes
- Oversee corrective actions related to audit findings
- Represent the GCP function in professional networks and meetings
- Maintain high-quality standards to ensure reliable clinical data
Berufserfahrung
- 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- eTMF
- ePRO
- eSource
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd 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.
Noch nicht perfekt?
- 1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Vollzeitnur vor OrtManagementBasel - BeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Idorsia Pharmaceuticals Ltd
Global Senior Pharmacovigilance QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel
IDIdorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality oversight for small-molecule drug trials and CRO collaboration at biotech with 1,200+ employees. Extensive GCP auditing and health authority interaction experience required. 40-hour week, 25-30 days vacation.
Anforderungen
- Background in Good Clinical Practices
- Master’s degree in scientific discipline
- Knowledge in Quality Assurance and Auditing
- Industry or health authority experience
- Experience in GCP Quality Assurance
- Experience in Clinical Research & Development
- Understanding of ICH-GCP and regulations
- Experience with clinical electronic systems
- Experience in cross‑cultural environments
- Excellent communication skills
- Problem solving and risk management
- Negotiation and influencing capabilities
- Reliability, conscientiousness, and adaptability
- Independent and collaborative work ability
- Ability to travel
- Fluency in English
Aufgaben
- Act as the key quality partner for clinical trial teams
- Provide expert guidance during study planning, execution, and closure
- Ensure compliance with regulatory requirements and Good Clinical Practice
- Collaborate with internal teams and CROs to support trial conduct
- Resolve quality-related questions with internal and external partners
- Identify risks and propose pragmatic solutions
- Escalate significant quality issues when necessary
- Develop and deliver GCP and clinical quality training
- Optimize quality processes, tools, and clinical systems
- Lead health authority inspection preparation and follow-up
- Conduct audits of sites, vendors, and processes
- Oversee corrective actions related to audit findings
- Represent the GCP function in professional networks and meetings
- Maintain high-quality standards to ensure reliable clinical data
Berufserfahrung
- 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- eTMF
- ePRO
- eSource
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia Pharmaceuticals Ltd 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.
Über das Unternehmen
Idorsia Pharmaceuticals Ltd
Branche
Pharmaceuticals
Beschreibung
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
Noch nicht perfekt?
- 1201 F. Hoffmann-La Roche AG
QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorKaiseraugst - 1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Vollzeitnur vor OrtManagementBasel - BeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Idorsia Pharmaceuticals Ltd
Global Senior Pharmacovigilance QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel