Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Full-timeOn-siteSenior
Basel
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BEBeOne Medicines I GmbH
Senior Manager, GCP Inspection Lead(m/w/x)
Basel
from CHF 141,800 - 177,300 / year
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- other – Business Fluent
Tools & Technologies
- Microsoft Office Programs
- GCP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH 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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BEBeOne Medicines I GmbH
Senior Manager, GCP Inspection Lead(m/w/x)
Basel
from CHF 141,800 - 177,300 / year
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- other – Business Fluent
Tools & Technologies
- Microsoft Office Programs
- GCP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH 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
BeOne Medicines I GmbH
Industry
Pharmaceuticals
Description
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Not a perfect match?
- Idorsia Pharmaceuticals Ltd
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