Manager Compliance, Quality Projects, Qualification & Validation / 08-5097

Sanofi Pasteur in the USA is a leader in the research, development, manufacture, marketing and sales of vaccines and immunological products because here we clearly see a better tomorrow for all mankind.We have a wide range of vaccines that protect against 20 diseases, but we believe there is still much work to be done. On every continent there exists viruses and bacteria, and we won’t rest until they are eradicated and all people can live healthy, full lives. We’re confident we can achieve our goals. As a subsidiary of Sanofi Aventis, the global pharmaceutical corporation, we have access to the resources needed to continue our boundary-breaking innovations far into the future.Our US site is located in Swiftwater, Pennsylvania, among the scenic Pocono Mountains, sanofi pasteur is housed in state-of-the-art facilities on a 269-acre campus. It is here that our multidisciplinary teams of 1900+ professionals work together to develop and provide new and improved immunological products. Our company is comprised of three global functions: Research & Development, Industrial Operations, and Commercial Operations, as well as seven support functions: Communications, Corporate Development, Finance and Purchasing, Human Resources, Information Solutions, Legal and Corporate Affairs, and Public Policy.For those who wish to make a difference in the world by aiding in the development, production or marketing of vaccines that are critically important to public health, sanofi pasteur offers superb opportunities. Our modern research, production and administrative facility attracts exceptional talent from businesses and universities around the world. Our location offers our people the best of outdoor living close to the cultural, culinary and recreational attractions of Philadelphia and New York City.sanofi pasteur US is a place for those who desire a challenging and rewarding career without compromising their quality of life. If you have the passion, desire, ambition, vision and talent we’re looking for, we invite you to explore our opportunities and to apply online at: www.sanofipasteur.us

Position Description:

Individual will participate in review and approval of qualification and validation activities, including representation on project teams(s). Individual should have broad knowledge of qualification and validation activities such as cleaning, computer, automated systems, process, sterilization, equipment and methods, Individual is expected to communicate and advocate validation best practices. It is expected that the individual will work closely with Manufacturing Technology to ensure activities are robust by developing appropriate validation strategies. Individual will be responsible for ensuring the compliance of GMP/GLP, FDA and EU regulator and internal requirements. Individual must be able to identify deficiencies to management, recommend corrective actions and perform necessary follow up. Individual will also be expected to support activities relating to protocol deviations, the CAPA system, the Change Control system and incident investigations. Strong communication skills are a must, as individual will be working with various areas throughout Industrial Operations and Regulatory Affairs. This position has signatory responsibilities for all qualifications/validation issues associated with assigned area. Weekend work when requiredOvertime work when requiredExcellent interpersonal skills and must be able to work in a cross-functional team-based environmentWe are an equal opportunity employer M/F/D/V

Qualifications:

Minimum 5 years validation experienceBS/BA in Life Sciences or EngineeringWorking knowledge of FDA and EU requirementsMinimum 8 year in cGMP regulated environment.