Beschreibung
Manager - General -Respond by Date
Hours per Day 8
Hours per Week 40
Total Hours 216
Description
Senior e-Compliance Manager
Ensure that the operation of the project and the delivered product, service and data is in accordance
with external and internal regulations such as GxP, SOx, Data Privacy, Legal , Novartis Quality Manual …
Ensure that all efforts for compliance are focused according the Risk-Based-Approach (GAMP5).
Evaluate and recommend an effective and appropriate project eCompliance approach amidst complex landscapes and scenarios.
Ability to develop in parallel new eCompliance procedures based on the project approach .
Ability to effectively communicate quality issues and recommendations to improve eCompliance to Novartis Senior Management.
Ability to create a climate of collaboration and teamwork among team members and key stakeholder groups.
Additional Skills
Computerized System Validation 4 (Very Strong) of 5 (Expert) and 7+ Yrs
GAMP5 – Risk based Approach 5 (Expert) of 5 (Expert) and 10+ Yrs
GxP and LifeScience Experience 4 (Very Strong) of 5 (Expert) and 7+ Yrs
Demonstrated leadership experience / Teamplayer 4(Very Strong) of 5 (Expert) and 7+ Yrs
Management Communication 5 (Expert) of 5 (Expert) and 10+ Yrs