Principal Regulatory Affairs Compliance Consultant - Microbiology or Aseptic Pro

Parexel's Regulatory Consulting team is known for our unparalleled breadth and depth of expertise globally. Parexel Regulatory Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing!We currently have a home-based opening on our Regulatory Consulting Compliance Team for a highly experienced aseptic process subject matter expert to join the Consulting team as a Principal Consultant.As a Principal Consultant, you will provide expertise to our clients, including consulting on aseptic operations, sterility assurance, development and implementation of remediation plans for aseptic operations, gap analysis of client's environmental & personnel monitoring programs; evaluating client's approach to sterility assurance of products being manufactured; evaluating aseptic manufacturing processes and equipment for compliance to cGMPs; evaluating client's approach to validation of aseptic processes; and assisting client's in applying microbiological aspects to product impact assessments. You will also be responsible for providing mentoring and coaching for aseptic operations, investigations impacting sterility of product, and aseptic processes for our clients.A Principal Consultant must have the knowledge and ability to provide clients with recommendations on how to bring their processes and procedures into compliance with cGMPs and industry best practices; the ability to write clear, concise, objective reports and recommendations; and effectively communicate and interact with our clients.Qualifications

PhD in a scientific discipline or other advanced degree or equivalent in engineering preferred.Aseptic process expert (Microbiologist) with 10+ years of operational experience with sterile and aseptic processing combined with expert level knowledge of FDA requirements and regulations is required.Reputation as an emerging leader in the field with sustained performance and accomplishment.Previous industry experience in Quality and/or Compliance or previous experience as a Consumer Safety Officer, Compliance Investigator, or similar role, including numerous years of experience planning and conducting complex regulatory inspections and in-depth investigations coupled with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA) are required.Expert knowledge of scientific principles and concepts.70%+ Domestic and International Travel Required

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