Job Description

MS&T Processes & Standards Lead Location - Hyderabad #LI Hybrid About the Role: . Drive the establishment, maintenance and continuous improvement of MS&T global business processes and systems to ensure adherence to internal Novartis requirements, standards and external regulations. Develop MS&T related standards that can be applied at all sites to improve efficiency and compliance. Lead MS&T, strategy planning, validation policies, act as global quality system owner Key Responsibilities: . Responsible for establishing and maintaining the MS&T global standards for key Business Processes/Quality Systems (e.g. product improvement portfolio, manufacturing robustness review board). Provide guidance and oversight to manufacturing sites. . Interface to Quality Systems & Standards and Novartis Group Quality Systems and Standards Council (QSSC) to ensure the business requirements and expectations are maintained within the standards. . Responsible for transforming MS&T relevant business processes from reactively managed to proactively define and from quantitatively managed to continuously optimizing. Maintain knowledge of and influence current industry trends and Health Authority expectations to influence internal standards accordingly to incorporate and translate into business processes. . Collaborate with quality function to ensure alignment with QA and product stewardship, drive the implementation of Internal Release Limits and ensure alignment in the product improvement agenda with respect to test method improvement. Responsible for alignment of MS&T Systems and Standards through direct interface with Business Units representatives . Proactively review the Quality Systems to identify MS&T trends across the organization and to ensure alignment with industry expectations. Ensure alignment with Novartis Quality System (QMs/QDs/ SOPs). Review and provide feedback of all relevant Quality Modules and Directives. Provide input into the alignment and update of global standards. . Evaluate, develop and support the implementation of the \'product improvement portfolio\' and \'manufacturing robustness review board\' for use across the platforms. Benchmark against internal Novartis and external industry standards with the aim of achieving world class standards and practices, with best practice sharing across the platform sites. . Champion the Novartis Values & Behaviors and act as a role-model of leadership to foster an inclusive and high performing culture which develops capability and talents. Diversity & Inclusion / EEO Minimum Requirements Essential Requirements: : . 12+years of experience in Technical Development, Pharmaceutical, Chemical or Biological Operations. Broad experience in Technical Development, QA/QC line functions and/or manufacturing departments. . 5+yrs of experience in MS&T, expert in process development, new product launches, life cycle management of sterile, OSD, Large Molecule, Small Molecule or gene therapy platform. . Extensive experience in global and local MS&T, QA and QC business processes, standards, regulatory requirements and project management, IT systems and operational excellence. . Demonstrated matrix leadership skills through global project teams and/or departments. Knowledge of external and internal quality standards and industry best practices, preferable. . Experience in implementation of validation policies, computer system validation programs. Strong knowledge and hands on experience in Health Authority Audits. Good knowledge of regulatory requirements for USFDA, MHRA, EMA and exposure to major regulatory audits and compliance. . Self-motivated and driven, proactive approach on how the existing process/product can be improved further within the compliance guidelines. Experience in leading operational excellence projects. Desirable Requirements: . University degree in Pharmacy, Chemistry, Engineering or equivalent discipline additional knowledge of Quality Systems and Business Process Management. 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. 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: . No video provider was found to handle the given URL. See for more information.

foundit