Manager R&D Quality Assuance Clinical Batch Release / 08-5166

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:

• Review of CTM(Clinical trial material)Manufacturing RecordsResponsible for the timely review and approval of manufacturing records for completeness and accuracy. This includes the review of batch specific sterilization records (if applicable) to verify they meet requirement, the review of process specific records for conformance, the review of analytical records (and associated Certificates of Analysis) to verify all required testing has been performed and all testing meets requirements prior to release, the review of environmental monitoring data as required prior to batch release, and the review of deviation/change control forms to verify acceptability of issues and their resolutions.Responsible for ensure site archiving rules are followed for batch records.• Release of Clinical BatchesResponsible for prioritized release of all clinical batches (and associated steps) produced either in-house or made on contract according to regulatory and internal requirements as well as in accordance to company strategic objectives. The release activity includes the verification of all associated reviews to ensure consistency of the overall batch record that all previous manufacturing steps including raw materials have been released prior to release of the batch and the verification that any associated deviations and/or other batch discrepancies have been resolved prior to release and approval of contractors for pharmaceutical manufacturing.• Oversight and Maintenance of Clinical Batch ProceduresResponsible for ensuring that clinical batch release procedures are in place and maintained according to regulatory requirements.Responsible for the modification, revision, and timely updating of clinical batch release procedures in accordance with regulatory and logistic requirements.Responsible for the review and approval of Product Stability Protocols prior to submission to appropriate Regulatory Authorities in France and Canada. In the US, perform by Director QA.Responsible for assigning expiry dates to clinical batches based on stability test results and in accordance with the use of the batch in clinical trials.Responsible for the regulatory submission of all relevant documents declaring the intended use of batches in clinical trials.Responsible for the usage decision of CTM manufactured products that were subjected to one or several cold chain breaks.Responsible for carrying out all required SAP transactions for product review and release.Responsible for monitoring an inventory list of all batches released and providing a monthly update to appropriate levels of management.Responsible for the monthly tracking/monitoring, evaluating, and reporting to R&D QA site metrics coordinator pre-defined quality metrics related to batch review and release, as well as recommendations for improvements and/or resolutions to trends identified.• Project Team RepresentationResponsible for representing R&D QA on project team and/or sub-teams and/or project working groups in order to provide direction on quality issues and regulatory compliance. This includes assuming the role of principle communication on the project within R&D QA, representing R&D QA overall with expertise at project team meetings, assisting functional/platform leaders in reviewing project needs, discussing issues, and developing clear recommendations with action plans integrated into project plans, managing the position of the project plan that relates to R&D QA, ensuring R&D QA activities for the project are performed, negotiating objectives relative to the project and personal objectives, and assisting in the project's budgeting exercise for R&D QA.• Collaboration on Local & Global Quality InitiativesParticipates in on-going global quality initiatives. Keeps updated on new rules and industry regulations, and to define and align internal quality systems with best practices.Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.Participates in global R&D QA initiatives impacting quality systems to ensure harmonization of processes. Works with global R&D QA colleagues on action plans for remediation and/or implementation.Participates in local customer service initiatives including those focusing on improving R&D QA support.• Training and InteractionsResponsible for overseeing junior colleagues as well training new and/or existing colleagues on specific procedures/processes when identified and/or designated by Department Head.Responsible for communicating and collaborating on a timely basis with the respective project team representative +/or back-up to ensure continuous and consistent service.Responsible for all local communication reports and updates (e.g. keeping direct supervisor appraised of local quality issues, completing monthly reports, completing metrics worksheets, etc.).Responsible for interacting with QA GCP, GLP, IO QA, QC, RA, PD, Clinical departments as required.Works with R&D QA colleagues at the site to receive quality training, setting initiatives and action plans, and implementing resolutions.CHALLENGES:• The incumbent is responsible for managing the quality and compliance risks associated with the review and release of product produced in clinical trial material (CTM) manufacturing in accordance with cGMP standards, and regulatory and internal requirements.• Familiarity with aseptic manufacturing processes, filling operations, cleaning, sanitization, sterilization techniques, aseptic techniques, cleanroom management and aseptic process control and all the relevant tests is fundamental in performing the job.• This position requires a strong understanding of quality, and teamwork attributes as the incumbent will associate with a team of individuals/professionals from various R&D and/or QO departments to resolve problems or implement quality systems. An ability to negotiate and communicate with people in a positive manner while identifying, discussing and rectifying problems is a requirement of the position. The nature of these relationships includes the range from senior management staff to direct line employees.• As these activities have an impact on multiple work units (e.g. R&D, QC, Planning, Distribution) and on the entire organization, this position must ensure the availability of product for further manufacturing, and/or release to clinical trials, by the timely and accurate review of specific batch documents. Improper release of product to clinical trials could result in jeopardy of the safety of clinical research subjects.• The ability to facilitate and prioritize the issues identified with the review and release of product production CTM manufacturing in a timely fashion requires flexibility, constructive and/or innovative thinking to resolve and manage the process.• Decisions the incumbent may make are based on multiple sources that will require further investigation or interpretation. Work consists primarily of duties requiring resolution through the choice of several learned policies and procedures with respect to analytical assessments, innovative approaches, and the like. The incumbent will be required to actively balance the quantity of their work with an acceptance level of quality while ensuring compliance.We are an equal opportunity employer M/F/D/V

Qualifications:

Education/experience• (Minimum) BSc Degree, specializing in Biology, Microbiology, Biochemistry• In France, Pharmacy degree is required• (Preferred) Master of Science Degree, specializing in Biology, Microbiology, Biochemistry• 6-10 years related experience in Manufacturing and QA• Excellent report writing and communication skills• Excellent knowledge of the GMPs for US, Canada and Europe• For French : English fluency requiredCertifications• ASQ Certified Auditor• ISO Certified Auditor• Quality System certification training from a recognized institution are all assets