1201 F. Hoffmann-La Roche AG
QA Manager(m/w/x)
Full-timeOn-siteSenior
Kaiseraugst
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IDIdorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
6 years
Education
Master's degree
Languages
English – Business Fluent
Tools & Technologies
eTMFePROeSource
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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IDIdorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
6 years
Education
Master's degree
Languages
English – Business Fluent
Tools & Technologies
eTMFePROeSource
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Idorsia Pharmaceuticals Ltd and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Idorsia Pharmaceuticals Ltd
Industry
Pharmaceuticals
Description
Idorsia is a biopharmaceutical company focused on discovering, developing, and commercializing transformative medicines.
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