ITM Isotope Technologies Munich SE
Director Clinical Quality Assurance/GCP(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Garching bei München
DA
Daiichi Sankyo Europe2 Tage
Director E-Compliance / IT Governance(m/w/x)
Vollzeit
Senior
Keine Angabe
München
Nejo KI-Zusammenfassung
In this role, you will lead the E-Compliance team, ensuring IT and Data Governance for global QA systems. Your day-to-day responsibilities will include managing compliance, driving validation strategies, and collaborating with teams to enhance quality and regulatory adherence.
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Anforderungen
- •Minimum 10 years in GxP roles
- •At least 5 years managing Computerized Systems Validation or quality IT systems globally
- •Strong knowledge of ISPE GAMP 5 (1st edition required, familiarity with 2nd edition preferred)
- •Proven leadership with global project and people management experience
- •Bachelor’s degree in a scientific or technical discipline required; Master’s preferred
- •Fluent English and excellent communication skills
- •Enterprise mindset and strong project management skills
- •Deep understanding of quality management systems, GxP regulations, computerized system validation, IT governance, data integrity, and regulatory expectations
- •Excellent collaboration, conflict resolution, and shared accountability skills
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
10 Jahre
Deine Aufgaben
- •Lead the Regional/Local E-Compliance team
- •Ensure alignment with Daiichi Sankyo’s DX Data Governance as Data Steward for core systems
- •Manage the IT QA portfolio and oversee GxP projects
- •Drive Computerized Systems Validation (CSV) compliance by defining risk-based validation strategies
- •Provide operational oversight of GxP-related IT systems globally
- •Develop global principles and strategies for CSV, IT governance, and data integrity
- •Collaborate with functional QA teams to tailor strategies
- •Drive the digital quality roadmap and process automation aligned with QMS strategy
- •Lead global validation strategy for Generative AI deployment in GxP environments
- •Implement Global QA governance for systems like ALTOS, eQMS, QualityDocs, and VLM
- •Ensure compliance of global Quality IT systems
- •Oversee IT vendor selection and management for CSV activities
- •Implement IT quality strategy in alignment with business goals
- •Provide e-Compliance support for global system deployments
- •Support inspections and audit readiness with DX-IT and Functional QA
- •Build and mentor a high-performing global E-Compliance team
- •Foster collaboration with DX-IT to meet IT and regulatory requirements
- •Ensure quality oversight for third-party vendors and CSV activities
- •Serve as primary contact for global RDPV QA CSV activities
- •Identify and mitigate computerized system risks with cross-functional teams
- •Represent QA in IT/CSV governance and communicate risks to leadership
- •Lead projects to advance organizational technology and quality
- •Ensure timely closure of operational gaps in e-Compliance QA and IT activities
- •Collaborate with QA audit teams to communicate IT-related observations and risks
Sprachen
Englisch – verhandlungssicher
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