Quality Assurance Senior Specialist

Senior Specialist QA Remote any time zone OK Does the thought of building an entirely new digital quality management system, excite you? Do you love to design and streamline processes within a hard-working team? If you have a passion for streamlined, user-friendly Quality Management System enabled by digital and want to be part of 's mission to serve patients - every patient every time - then check out this exciting new opportunity. Be part of the Digital Quality Management System, a transformation that will encompass the process redesign, simplification, and sustainment within a new technology ecosystem of advanced analytics and system integrations. When completed, the Digital Quality Management System will be a cornerstone for the Quality End-to-End Transformation delivering a streamline and modernized Quality Management System to handle the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, functional areas and partner groups within the Corporate Quality Management System organization. Under general supervision, provide tactical support activities to Quality Management System Lead. Specific responsibilities include but are not limited to: • Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across Operations and R&D, to the Digital QMS platform for health and control processes. • Leads Digital QMS audit & inspection readiness, deviations and change control activities • Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations • Manages and provides oversight of documents / records within the Quality Management System • Oversight of process key performance indicators and metrics • Manages external contractors providing services to the Digital QMS • Working across teams managing priorities Preferred Qualifications: • Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards • Ability to converse technically with mechanical, electronic, software, and quality engineers Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304) • Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations • Experience with risk-based Supplier Quality Management process. • Management of Global Inspection and Audit programs • Proficient working on multiple projects in a deadline driven environment • Strong decision making and organization skills with the ability to prioritize multiple business priorities. • Experience in project management, process improvement and quality system management • Effective verbal and written communication skills (writing and presentations) in English