Job Description General Summary: The Operational Area Quality Senior Manager will provide quality assurance management for design and development, quality systems and compliance activities working cross-functionally within Vertex. Key Duties and Responsibilities: Lead/ facilitate all DP and DS Product Quality Key Performance Indicators. Assist with Product Quality Investigation workflows like Deviations, Lab OOS, CAPA's, and Change Control Lead/facilitate with Product Quality Risk Management Processes and create and maintain DS and DP Product Quality Risk Register. Being part of the Pre-Approval Inspection Team, assist CDMO site to be ready for a successful global agency Identify, facilitate and implement continuous improvement for quality processes Assist with Quality Integration between Alpine and Vertex Processes Assist with DS and DP Batch Record Review and Release 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 (DS) and Drug Product (DP) Manufacturing as Technical Quality Subject Matter Expert Act as QA Technical Subject Matter Expert in global Regulatory Inspections Created, authored, and successfully closed DS and DP Product Deviations, Laboratory out of specifications, CAPA's Reviewed and released executed DS batch records both clinical and commercial biologics products Has in depth expertise in creating and managing Product Quality Risk Management Has in depth experience with EDMS, EQMS, LMS 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. Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers. 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 Familiarity with molding and assembly methodologies ASQ certifications (Certified Quality Engineer, Certified Quality Auditor, Six Sigma) Working knowledge of ISO 13485, ISO 14971 and combination product standards Blueprint literacy including GD&T Education and Experience: Bachelor's degree in relevant field is require