Global Quality Management System Rdq Specialist

Summary Manages Quality aspects and projects within area of responsibility -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems Key Responsibilities As QMS Specialist ensures documents are in compliance with Good Documentation Practice GDP and internal procedures providing a QMS review and QC check prior to final QA approval As CR manager support Development Authors and track Change Requests CRs in 1-DMT ensuring timely progress and release of good Quality documents in alignment with stakeholder As SOP Manager for assigned Development Line Function manage stakeholder access and approval workflow in ESOPS Collaborate with global and local teams to resolve document lifecycle issues and ensure training release on time Active participation in Global projects related to QMS e g Global QMS simplification CQMS Optimization and in Global Boards e g GPGV representing RDQ QMS Support governance activities by monitoring CR metrics preparing reports and facilitating cleanup initiatives Provide support for QMS integration for newly acquired companies SPOC for Business Line Functions for Document Lifecycle Management Support audits and inspections related to QMS topics SPOC for the QMS tools Training systems document maintenance Provide technical or administrative support for users Maintain access to DLM and LMS stakeholders Perform validation activities in 1-DMT and feed training BOT Minimum Requirements Bachelor Technical degree in Life Sciences or related fields Advanced degree and or MBA an advantage Excellent English language skills Significant relevant work experience 5 years in the pharmaceutical industry or public health sector in the area of R D Quality or Training Demonstrated knowledge in implementing managing robust Document management systems and Learning Management Systems setting global quality controls in a regulated area Sound understanding of regulated activities health authority expectations and GxP paired with good business understanding Role model for the Novartis values and behaviours and exemplary interpersonal skills Excellent leadership interpersonal communication negotiation and problem-solving skills Ability to innovative when faced with opportunities or challenges Ability to influence and drive facilitate changes across the organization 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 https www novartis com about strategy people-and-culture You ll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewards 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 Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to diversityandincl india novartis com and let us know the nature of your request and your contact information Please include the job requisition number in your message 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 https talentnetwork novartis com network Skills Desired Compliance Requirements Continued Learning Dealing With Ambiguity Decision Making Skills Document Management System DMS Gxp Industry Standards Learning Management Systems LMS Quality Management Systems QMS Quality Standards Risk Management Self-Awareness Technological Expertise