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Job Description General Summary: The Senior Manager Quality Technical GMP Drug Substance will be a hands on QA Technical Subject Matter and In collaboration with external CDMO's, Contract Laboratories and internal cross-functional teams within Vertex. Key Duties and Responsibilities: Lead/ facilitate all kinds of Drug Substance Product Events such as Lab OOS, Deviations, CAPA, Change Control Product Release Be present at CDMO site as Person-In-Plant to review and approve product specific protocols, reports, and Product Release and Distribution Be part of the Pre-Approval Inspection Team, assist CDMO site to be ready for a successful global agency inspectionsProvides quality assurance management in design and development activities of medical device products and facilitates the application of design controls and risk management. Support Design History File establishment, creation, approval and maintenance. Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to applicable design control regulations (21 CFR 820) and company policies and procedures. Review and approve design documentation including, but not limited to verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents (design and process). Support risk management activities including planning, design and clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting. Manage risk management file throughout product development cycle. Review new and modified product designs for quality characteristics, including manufacturability, testability, reliability, biocompatibility, sterility and conformance to product requirements. Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required. Provide leadership in all areas of the Quality System, including, but not limited to Root Cause Analysis, CAPA, Nonconforming Material Investigations and Reporting, Deviations, Change Control, Supplier Qualifications, and Audit support functions (internal and external). Provide leadership in the understanding and communication of medical device regulations to other disciplines. Know and follow applicable FDA regulations and policies that apply to one's job, and maintain the highest level of professionalism, ethics and compliance at all times. Knowledge and Skills: Direct Hands-on experience in BIOLOGICS Drug Substance Manufacturing as Technical Quality Subject Matter Expert Act as QA Technical Subject Matter Expert in global Regulatory Inspections Create, author, and successfully closed DS Product Deviations, Laboratory out of specifications, CAPA's Created and implemented GMP process, facilities, equipment continuous plans Review and release executed DS batch records both clinical and commercial biologics products Act as Person-In-Plant for DS Manufacturer Have In-depth knowledge and experience in QC Analytical and/or Microbiology Testing Implemented and used E-Quality Management Systems, Document Management System, Learning Management System Implemented and used E-Quality Management Systems, Document Management System, Learning Management System Possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it related to technical situations. Highly detail oriented with strong organization and prioritization skills. Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.) Practical knowledge and experience with statistical methods, including sampling size justification using Minitab or other statistical software Development and/or manufacturing experience