CHEPLAPHARM Arzneimittel GmbH
Global Head of Quality(m/w/x)
Full-timeWith HomeofficeSenior
Greifswald, Berlin, Binningen
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121201 F. Hoffmann-La Roche AG
Senior Quality Lead(m/w/x)
Basel
Full-timeWith Home OfficeManagement
Nejo AI Summary
Designing and implementing QA strategies for global healthcare access. Strategic thinking and digital literacy required. Audit management from preparation to reporting.
Requirements
- Proactive, strategic thinking
- Thrives in collaborative, matrixed environment
- Passionate about driving Quality outcomes
- Strong digital and data literacy
- Comfortable asking challenging questions
- Extensive Quality Expertise
- Strong drug development process background
- Strong clinical trials background
- Robust cross-functional GCP experience
- Robust cross-functional GVP/PV experience
- Robust cross-functional Medical Devices/SaMD experience
- Proven track record leading Health Authority inspections
- Inspection readiness management
- Post-inspection management
- Advanced problem-solving skills
- Proactive, risk-based mindset
- Utilise data and data visualisation tools
- Exceptional relationship management skills
- Proven ability to negotiate effective solutions
- Proven ability to influence senior stakeholders
- Experience managing projects in global teams
- Experience managing projects in multicultural teams
- Passion for coaching others
- Passion for mentoring others
- Bachelor’s degree or equivalent in scientific field
- Bachelor’s degree or equivalent in quality-related field
- Advanced degree preferred
Tasks
- Design and implement QA strategies
- Partner with business stakeholders to define QA approach
- Assess risks and adapt strategies using CtQ framework
- Determine required audits and develop methodologies
- Manage end-to-end audit process from preparation to reporting
- Manage quality issues and track systematic findings
- Escalate significant risks to PDQ management
- Evaluate quality positions to drive compliance action plans
- Lead high-level risk presentations and strategic discussions
- Communicate with business stakeholders, Pharma, Legal, and Regulatory Affairs
- Lead preparation for Health Authority inspections
- Train staff for major regulatory inspections
- Present quality strategies and conclusions to inspectors
- Contribute to PDQ's long-term strategic direction
- Lead compliance projects
- Mentor and develop Quality Leads within the team
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- data visualisation tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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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121201 F. Hoffmann-La Roche AG
Senior Quality Lead(m/w/x)
Basel
Full-timeWith Home OfficeManagement
Nejo AI Summary
Designing and implementing QA strategies for global healthcare access. Strategic thinking and digital literacy required. Audit management from preparation to reporting.
Requirements
- Proactive, strategic thinking
- Thrives in collaborative, matrixed environment
- Passionate about driving Quality outcomes
- Strong digital and data literacy
- Comfortable asking challenging questions
- Extensive Quality Expertise
- Strong drug development process background
- Strong clinical trials background
- Robust cross-functional GCP experience
- Robust cross-functional GVP/PV experience
- Robust cross-functional Medical Devices/SaMD experience
- Proven track record leading Health Authority inspections
- Inspection readiness management
- Post-inspection management
- Advanced problem-solving skills
- Proactive, risk-based mindset
- Utilise data and data visualisation tools
- Exceptional relationship management skills
- Proven ability to negotiate effective solutions
- Proven ability to influence senior stakeholders
- Experience managing projects in global teams
- Experience managing projects in multicultural teams
- Passion for coaching others
- Passion for mentoring others
- Bachelor’s degree or equivalent in scientific field
- Bachelor’s degree or equivalent in quality-related field
- Advanced degree preferred
Tasks
- Design and implement QA strategies
- Partner with business stakeholders to define QA approach
- Assess risks and adapt strategies using CtQ framework
- Determine required audits and develop methodologies
- Manage end-to-end audit process from preparation to reporting
- Manage quality issues and track systematic findings
- Escalate significant risks to PDQ management
- Evaluate quality positions to drive compliance action plans
- Lead high-level risk presentations and strategic discussions
- Communicate with business stakeholders, Pharma, Legal, and Regulatory Affairs
- Lead preparation for Health Authority inspections
- Train staff for major regulatory inspections
- Present quality strategies and conclusions to inspectors
- Contribute to PDQ's long-term strategic direction
- Lead compliance projects
- Mentor and develop Quality Leads within the team
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- data visualisation tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
Not a perfect match?
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