Manager Chemistry, Manufacturing and Controls (CMC) Services
Inseriert am: 02.05.2019
Manager Chemistry, Manufacturing and Controls (CMC) Services In Philip Morris Products S.A., Science and Innovation, in Neuchâtel, Switzerland Philip Morris International (PMI) understands the millions of women and men who smoke cigarettes and are looking for less harmful, yet satisfying, alternatives to smoking. We have a commitment to our employees and our shareholders. We will fulfill that commitment by pursuing this long-term vision for success. Society expects us to act responsibly. We are doing just that by designing a smoke-free future. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. To strengthen our CMC Governance Team, we are looking for someone who is curious to join a highly dynamic work environment and shaping the newly built organization by applying leadership skills in cross functional and matrix team, and willing to drive for success in an ambiguous environment. In this new role, you will develop and own the document / knowledge management system for the CMC Governance Team. Your experience in QMS (quality management system) or LIMS (laboratory and information management system) will help you to build and maintain the foundation for transferring CMC data into regulatory approvable documents and maintain information changes in a retrievable and traceable system. Alternatively experience with electronically systems used in library science would be similarly appreciated. Responsibilities will include: Define and deploy documentation / information management strategy supporting the content of CMC for current and upcoming products Ensure appropriate evidence that the CMC are generated at source. Verify implementation and review of evidences for compliance to our Quality Management System and Standards Support the CMC Managers in the consolidation and review of technical dossiers. Collect and review evidence substantiating CMC narrative, appendices and changes Define and maintain an information and knowledge management system to enhance the collection and centralization of the CMC’s relevant evidences and evolutions Ensure CMC information and knowledge management system works in an integrated way and ensure appropriate training is spread within the organization to maximize the efficiency and benefits of the system Support the standardization of the CMC’s information structure to allow for better flexibility and modularity of dossiers, including traceability between CMC narrative and subset of evidences Promote knowledge sharing through a communication platform centralizing up-to-date product knowledge, promotion of information exchange between stakeholders and the organization of events Continuously enhance and maintain the knowledge management system in regards of current practices and new requirements. You will have: Master’s or Bachelor’s degree in Information System, Library Science, Life Sciences or Engineering Previous experience as CMC submission manager in life science, cosmetic, food or other industries that require high standards of control and change management Substantial experience in development of Data Management / Laboratory & Information Management System (LIMS) and Quality Management System (QMS) Proven experience with full lifecycle of complex products, from development to commercialization, regarding documentation and change control Demonstrable experience in project management Experience in regulatory submissions within Electronic Devices or Consumer Goods Production is an advantage Proven ability to influence cross-functional teams High degree of creativity, flexibility and resourcefulness Excellent communication and presentation skills (verbal and written) Fluent in both verbal and written English. A valid Swiss work permit or Swiss or EU-25 EFTA citizenship is required to apply for this position. Philip Morris International: Building a Smoke-Free Future Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. PMI's smoke-free IQOS product portfolio includes heated tobacco and nicotine-containing vapor products. As of Dec. 31, 2018, PMI estimates that approximately 6.6 million adult smokers around the world have already stopped smoking and switched to PMI’s heated tobacco product, which is currently available for sale in 44 markets in key cities or nationwide under the IQOS brand. For more information, see our PMI and PMIScience websites.Apply now