DirecciónAbout the Role
Location:#LI#CDMX#Hybrid About the role: This opportunity offers candidates a chance to gain global exposure, work in a critical compliance role, support organizational goals, and advance their professional development. By overseeing the Change Control process and promoting compliance records, candidates can contribute to the organization's success and open doors for future career advancement. Main Responsibilities: •Coordinate Change Control activities with the Novartis Control Quality (NCQ)initiating/owning Change Request
•Facilitate meetings with the experts and partners of the change request to determine the required activities and time-lines. Detail the format of pre-work with the impact of each area
•Initiate change Requests on behalf of NCQ (when applicable) in the platform applicable for the Change Control Progress, coordinate and supervise the change request activities (i.e., task completion, gate approvals, CR closure, etc.) on continues basis, making sure it adheres to the projected time-lines
•Ensure that the change has been evaluated, performed and implemented taking into account all aspects of quality; validation, registration, continuity of business, etc., until it is closed. Follow-up on the issues, time-line extensions with responsible SMEs
•Regularly connect with customers and partners to collect feedback on support services, report result status and continuously acquire process knowledge
•Report to the Quality Assurance of changes emerged from the divisions which affects other sites, other BU or authorized third parties for the corresponding impact assessment. Provide the vital training to staff applicable to the Change Control process and IT systems
•Follow-up on the actions determined by audits, self-inspection, Manual quality, etc. for the Change Control aspects
•Raise IT tickets for technical issues, registration/deregistration users of the existing Change Control platform. Support NCQ and Global Change Control activities/initiatives. Provide guidance for the Change Control process improvements/simplifications
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
•Breadth QA in pharmaceutical ind./ biotech
•English Proficiency
•Knowledge of IT Applications & tools Quality Standards Quality Assurance
•3 Years of experience in similar roles
•Portuguese desireable Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
