Italy Job Openings
Teva Pharmaceuticals
Associate Director IT Quality and Compliance - TAPI
Rho
September 18, 2024
- Continuously improve the TAPI c Gx P Computerized Systems policies, standards, procedures, tools and training.
- Provide QA IT review and approval on all globally managed Computerized System deliverables
- For some globally managed Computerized System, represent site users, as System Business owner. Manage site inspection readiness and support with regards to globally managed Computerized Systems.
- Guide TAPI Sites IT and IT QA on inspections trends, observations, authorities' expectations and best practices that can mitigate gaps.
- Deliver training programs to TAPI Computerised systems owners.
- Support sites with any IT related project(s) as required.
- Support sites with computer systems validation, infrastructure qualification and systems life cycle management, together with any remediation needed.
- Conduct Gx P computerized systems gap assessments/evaluations with applicable regulations
- Bachelor’s degree in Engineering, Computer Science, Science or other related field.
- Minimum of 10 years of experience and strong overall understanding of Computerized System Validation and quality business processes supporting global functions, manufacturing and laboratory operations
- Working experience in API/Pharma companies in a similar role is a must.
- Proven management capabilities managing direct and matrix teams and projects
- Strong understanding of regulations and industry standards such as 21 CFR Part-11, Eudralex Annex-11, GAMP 5, Data Integrity regulatory and industry Guidance and proven ability to pragmatically apply these regulations to operate in an efficient and effective fashion.
- Exposure, working experience and knowledge of GAMP -5 and SCADA systems
- Ability to work with external vendors/suppliers, experience with IT supplier management is desirable.
- Advanced leadership skills, business strategy, accountability, proven experience leading and motivating global, cross-functional teams.
- International experience - a must.
- Advanced experience in working with matrix environment.
- Advanced negotiation skills.
- Advanced knowledge and experience in problem solving.
- Advanced communication skills – written and verbal.
- Advanced agility leadership and teamwork skills.
- Must be able to travel based on business need; up to 30% when critically required (domestic and international).
- Fluent in English – a must
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