SUSONITY
Director Real World Evidence (N&I)(m/w/x)
Full-timeOn-siteSenior
Darmstadt
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SUSUSONITY
Director, Head of Inspection & TMF Center of Excellence(m/w/x)
Darmstadt
Full-time, Part-timeOn-siteSenior
Nejo AI Summary
Global oversight of Health Authority inspections and GDO training programs for life science innovation. 15+ years pharmaceutical R&D experience required. Operating model for 'Always Inspection Ready' status.
Requirements
- PhD or MS in Life Sciences
- 15+ years Pharmaceutical R&D experience
- 10+ years multinational line management experience
- Deep expertise in GCP
- Deep expertise in global Health Authority inspections
- Deep expertise in TMF governance
- Deep expertise in eTMF platform design and implementation
- Proven track record in Risk-Based Quality Management
- Proven track record in delivering digital solutions for inspection readiness
- Strong leadership capabilities
- Experience building, mentoring, and advancing a high-performing, diverse team
- Exceptional stakeholder management skills
- Exceptional communication skills
- Experience guiding senior leadership
- Experience guiding cross-functional partners
- Demonstrated ability to sponsor training programs
- Demonstrated ability to drive inspections simulations
- Demonstrated ability to manage readiness initiatives end-to-end
- Familiarity with ICH regulatory expectations
- Familiarity with FDA regulatory expectations
- Familiarity with EMA regulatory expectations
- Familiarity with MHRA regulatory expectations
- Familiarity with PMDA regulatory expectations
- Familiarity with modern QA frameworks
- Fluency in English
Tasks
- Establish and lead global 'Always Inspection Ready' operating model
- Provide strategic oversight of Health Authority inspections
- Sponsor GDO training programs
- Lead portfolio-wide GDO inspection simulations
- Act as GDO Executive Inspection Lead for Health Authority inspections
- Continuously improve readiness frameworks through trend analysis
- Collaborate cross-functionally to enhance inspection readiness
- Own global TMF governance framework
- Ensure alignment with ICH E6(R2/R3), FDA 21 CFR Part 11, EMA, MHRA, and PMDA requirements
- Serve as business lead for TMF system
- Maintain global TMF Reference Model
- Establish global TMF health metrics dashboard
- Drive digital modernization through automation and AI
- Lead continuous improvement of TMF processes, tools, and systems
- Oversee GDO-wide audits and quality management
- Ensure risk-based, data-driven decision-making
- Foster culture of proactivity, accountability, and continuous improvement
- Manage high-performing, multinational team
- Set objectives and conduct performance reviews
- Define team structure
- Support career development and capability building
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP
- eTMF platform
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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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SUSUSONITY
Director, Head of Inspection & TMF Center of Excellence(m/w/x)
Darmstadt
Full-time, Part-timeOn-siteSenior
Nejo AI Summary
Global oversight of Health Authority inspections and GDO training programs for life science innovation. 15+ years pharmaceutical R&D experience required. Operating model for 'Always Inspection Ready' status.
Requirements
- PhD or MS in Life Sciences
- 15+ years Pharmaceutical R&D experience
- 10+ years multinational line management experience
- Deep expertise in GCP
- Deep expertise in global Health Authority inspections
- Deep expertise in TMF governance
- Deep expertise in eTMF platform design and implementation
- Proven track record in Risk-Based Quality Management
- Proven track record in delivering digital solutions for inspection readiness
- Strong leadership capabilities
- Experience building, mentoring, and advancing a high-performing, diverse team
- Exceptional stakeholder management skills
- Exceptional communication skills
- Experience guiding senior leadership
- Experience guiding cross-functional partners
- Demonstrated ability to sponsor training programs
- Demonstrated ability to drive inspections simulations
- Demonstrated ability to manage readiness initiatives end-to-end
- Familiarity with ICH regulatory expectations
- Familiarity with FDA regulatory expectations
- Familiarity with EMA regulatory expectations
- Familiarity with MHRA regulatory expectations
- Familiarity with PMDA regulatory expectations
- Familiarity with modern QA frameworks
- Fluency in English
Tasks
- Establish and lead global 'Always Inspection Ready' operating model
- Provide strategic oversight of Health Authority inspections
- Sponsor GDO training programs
- Lead portfolio-wide GDO inspection simulations
- Act as GDO Executive Inspection Lead for Health Authority inspections
- Continuously improve readiness frameworks through trend analysis
- Collaborate cross-functionally to enhance inspection readiness
- Own global TMF governance framework
- Ensure alignment with ICH E6(R2/R3), FDA 21 CFR Part 11, EMA, MHRA, and PMDA requirements
- Serve as business lead for TMF system
- Maintain global TMF Reference Model
- Establish global TMF health metrics dashboard
- Drive digital modernization through automation and AI
- Lead continuous improvement of TMF processes, tools, and systems
- Oversee GDO-wide audits and quality management
- Ensure risk-based, data-driven decision-making
- Foster culture of proactivity, accountability, and continuous improvement
- Manage high-performing, multinational team
- Set objectives and conduct performance reviews
- Define team structure
- Support career development and capability building
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP
- eTMF platform
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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
SUSONITY
Industry
Healthcare
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Not a perfect match?
- SUSONITY
Director Real World Evidence (N&I)(m/w/x)
Full-timeOn-siteSeniorDarmstadt - Döhler
Head of Group Third Party Manufacturing(m/w/x)
Full-timeOn-siteSeniorDarmstadt - Döhler
Senior R&D Excellence Manager(m/w/x)
Full-timeOn-siteSeniorDarmstadt - SUSONITY
Associate Director in Data Science, Digital Health Analytics and Innovation(m/w/x)
Full-timeOn-siteSeniorDarmstadt - SUSONITY
Senior Due Diligence Lead(m/w/x)
Full-timeOn-siteSeniorDarmstadt