Company DescriptionEntrepreneurialSpirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’soldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.A need has arisen for a dynamic individual to join our QA team as a part-time consultant to deliver assurance of quality throughout MTDA. The selected Consultant will assist the Senior Director of QA, MTDA in the ongoing delivery of an integrated, coordinated and robust PV QA program. Duties will touch upon all aspects related to the development and maintenance of an MTDA Quality system, including: SOPs, audits, inspection preparation, QA metrics, regulatory intelligence, process mapping, computer validation, etc. The consultant will also workcollaboratively with the Manager of QA, MTDA to provide day-to-day assurance of: Protectionof SubjectsVeracityof DataLegalProtection of CompanyThis fixed-term 12-month consulting assignment offers a flexible 4-day per month schedule.Job DescriptionSupervise PV activities within MTDA under Senior Director QA.Manage own workload to ensure appropriate coverage of projects and activitiesProvide QA input to MTDA working groups and systems development as appropriateProvide advice on QA, PV matters to MTDA staffLiaise with Regulatory Affairs Department in maintaining as awareness of on-going regulatory changesParticipate in internal and external meetings as appropriateLiaise with relevant parties to arrange the audits as required by audit plansPerform Internal Process Audits of MTDA processesPrepare in a timely manner [30 days] reports of audits performedDistribute relevant audit reports in accordance with MTDApolicyAssist Senior Director of QA, MTDA in providing local US perspective in relation to global activities and systems arising from MTPCTo liaise with QA MTPC & MTPE as required on global programsAssist Senior Director of QA, MTDA in hosting PV related audits and regulatory inspections ofMTDA activitiesQualifications Minimum of a Bachelor's degree in scientific discipline or related field Minimum of 5 years of experience as ‘stand-alone’ auditor; i.e. performing audits alone. Experience with at least 2 regulatory inspections; at least one of which was an FDA PV Inspection. Related professional association membership (e.g., DIA, SQA, etc.) Proficiency in common office software (Windows, MS Office Suite) Ability to perform CSV audits is an advantageWillingness to travel approximately 50% both domestically and internationally.Additional InformationOur Value Proposition:Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.