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Head of Compliance and Quality Governance(m/w/x)
VollzeitVor OrtSenior
AI/ML
Data Science
Nejo KI-Zusammenfassung
Establishing governance frameworks and acting as senior escalation authority for technology compliance at a global pharmaceutical company. 10+ years senior leadership in regulated industries with deep GxP, CSV, GDPR, and ISO expertise essential. High autonomy in defining global compliance strategy.
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Anforderungen
- 15+ years IT domain experience
- 10+ years global multidisciplinary team management
- 10+ years Technology, Compliance, Quality, or Risk in regulated industries (biotech, pharma, medical devices) at senior leadership/executive level
- Deep expertise Quality Management Systems, GxP, CSV, GDPR, regional health data regulations, ISO standards (e.g., ISO 27001)
- Proven leadership IT Service Management (ITSM) and governance processes (incident, problem, change, release, configuration, continuity)
- Extensive experience governing modern technology landscapes (cloud, digital platforms, data, AI/Automation, DevOps) in regulated environments
- Familiarity with data science and AI/ML concepts in compliance space (major plus)
- Excellence in managing/interpreting risks, deviations, CAPAs
- Transforming insights into sustainable improvements
- Balancing operational excellence, regulatory compliance, business value
- Adept at translating business goals into roadmaps
- Leadership through influence and partnership
- Aligning diverse global stakeholders
Aufgaben
- Define functional vision, strategy, and roadmap
- Transform business needs into high-value capabilities
- Act as a senior escalation and decision authority
- Define and own the Technology Compliance & Quality Governance strategy
- Establish clear governance frameworks
- Establish clear decision models and accountabilities
- Translate global biotech regulations into technology outcomes
- Translate corporate policies into technology outcomes
- Serve as a trusted partner for leadership
- Represent Technology in executive forums
- Represent Technology in audits and inspections
- Represent Technology in regulatory interactions
- Oversee end-to-end delivery of defined functions (e.g., QMS)
- Oversee the lifecycle of defined functions
- Ensure Technology adherence to GxP and CSV
- Ensure Technology adherence to data integrity and privacy
- Ensure Technology adherence to global regulations (FDA, EMA, ICH, ISO)
- Interpret regulations pragmatically and risk-based
- Lead enterprise-wide technology risk assessments
- Lead compliance maturity evaluations
- Ensure timely, effective remediation of findings
- Ensure timely, effective remediation of deviations
- Ensure timely, effective remediation of CAPAs
- Build, coach, and develop a high-performing global team
- Foster a culture of accountability and transparency
- Guide senior leaders on risk-based decision-making
- Define success metrics (KPIs/OKRs)
- Leverage data analytics for informed decisions
- Drive immediate operational improvements
- Drive strategic optimizations to achieve business goals
- Manage the immediate team's budget and resources
- Develop detailed business cases
- Conduct cost-benefit analyses
- Develop resource estimates
- Support new functional initiatives
- Support significant process changes
Berufserfahrung
15 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
Quality Management SystemsGxPCSVGDPRISO 27001ITSMclouddigital platformsdataAIAutomationDevOpsdata scienceML
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Roche erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei RocheÜber das Unternehmen
RO
PharmaceuticalsKaiseraugst
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
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