Fresenius Kabi SwissBioSim GmbH
Director R&D Operational Excellence & Performance(m/w/x)
Vollzeitnur vor OrtSenior
Eysins
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SUSUSONITY
Senior Director, Head of Inspection & TMF Center of Excellence(m/w/x)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading global 'Always Inspection Ready' operating model for Health Authority inspections. Deep expertise in GCP and global Health Authority inspections required. 3 days on site per week, access to growth opportunities.
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Anforderungen
- PhD or MS in Life Sciences
- 15+ years Pharmaceutical R&D experience
- 10+ years multinational line management
- 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 delivering digital solutions for inspection readiness
- Strong leadership capabilities
- Experience building, mentoring, advancing high-performing, diverse team
- Exceptional stakeholder management skills
- Exceptional communication skills
- Experience guiding senior leadership and cross-functional partners
- Sponsorship of training programs
- Driving inspections simulations
- Managing 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
- English fluency
Aufgaben
- Establish and lead a global 'Always Inspection Ready' operating model
- Provide GDO 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 and cross-functional collaboration
- Own the global TMF governance framework
- Ensure TMF alignment with key regulatory standards (ICH E6(R2/R3), FDA 21 CFR Part 11, EMA, MHRA, PMDA)
- Serve as the business lead for the TMF system
- Maintain the TMF Reference Model
- Establish a global TMF health metrics dashboard
- Drive digital modernization of TMF 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 a strong culture of proactivity, accountability, and continuous improvement
- Manage a high-performing, multinational team
- Set objectives for the team
- Conduct performance reviews
- Define team structure
- Support career development and capability building across varying seniority levels
Berufserfahrung
10 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – fließend
Tools & Technologien
GCPeTMF platform
Benefits
Karriere- und Weiterentwicklung
- Access and opportunities for growth
Lockere Unternehmenskultur
- Culture of inclusion and belonging
Flexibles Arbeiten
- 3 days on site per week
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