Job Description

Summary -Ensure compliance and further development, support, maintenance and constant review of the Quality Systems and support for projects as well as the reporting of the necessary performance indicators (KPIs) & quality indicators (KQIs). Support implementation of effective & efficient processes that fulfill regulatory requirements & expectations in a sustainable way for the global Novartis portfolio of products.Global QMS ManagerLocation - Hyderabad #LI Hybrid, Spain #LI HybridAbout the Role:Responsible for the development, implementation, and continuous improvement of owned processes within Third-Party Management Global Quality System and its Global procedures and standards in compliance with cGMP/ICH, Regulatory Authority, and Novartis Group Quality Manual requirements and Policies. Maintain knowledge with current industry trends, Health Authority expectations and incorporate them into Novartis QMSKey Responsibilities:

• PO (Process Owner) for Supplier Lifecycle Management (Third Party Approval, Exit) and Quality Agreements. Performs PO responsibilities in a timely manner in collaboration with QSO and the network of Functional Representatives.
• Support execution of the Quality System strategy as per defined timelines and updates it where needed Develop and maintain a compliant, effective, and efficient process. Support the execution of Annual Quality System Review. Drive simplification and optimization to the processes and document landscape related to the processes under responsibility. Review and update definitions for terms belonging to the Quality System under the scope. Review the list of documents under Process and define applicability using the dimensions set up and document landscape architecture. Assess the emerging technology specific needs together with the respective experts and adapt Quality System processes and procedures as applicable.
• Support QSO with ensuring compliance to regulations through timely assessment of newly issued GxP requirements and incorporation into Novartis QMS as needed. Support QSO with QMS integration of acquired companies as needed. o Participate in benchmarking activities as applicable and keep up to date with industry standards through external engagement. Author - as required - of QMS documentation related to owned process. Act as SME for Event Risk Control and Third-Party Master data.
• Act as a SME or Business System Owner for respective IT system including maintenance and continuous enhancement (i.e. 1QEM related to third party tasks, TPRM - Third Party Risk Management and MDGS - Master Data Governance System) for Quality/GMP. Interact with main stakeholders/ other functions / platforms/sites / entities to improve the quality and compliance of owned processes. Establishes or support the maintenance and use of the communication channels (community calls, participation, when needed, on the Event triggered meetings, committees, etc.).

• Support or drive quality related initiatives in Global QMS or provide SME inputs, support the roll out to Novartis functions where suppliers are managed. Drive improvement projects across functions as needed. To be externally engaged by maintaining current knowledge of local and international regulatory and legislative requirements and trends. Support as advisor or SME any assigned specific Global QMS activities or projects as required.

Essential Requirements:

• Fluent spoken and written English; second language desirable
• Thorough knowledge of cGMP requirements - At least 10 years experience in pharmaceutical industrial Quality and Compliance related activities or strong proved background and knowledge in GMP operations (e.g. Manufacturing and Science).
• Desirable supplier management oversight background. Strong analytical skills and understanding of risk management fundamentals / tools. Good interpersonal skills, organizational, analytical, intercultural communication, and negotiation.
• Team and consensus builder, with definitive and authoritative decision-making ability and experience in an matrix organization Experience working in a global matrix organization preferred
• Experience in supplier approval process, quality agreement management, design process and systems, stakeholder management at different site level

Why Novartis: Our purpose is to reimagine medicine to improve and extend peoples 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:Youll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.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: .Skills Desired Compliance Requirements, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Quality Management Systems (QMS), Quality Standards, Risk Management, Self-Awareness, Technological Expertise, Waterfall Project Management

Novartis