Senior Quality Specialist

  The Quality Specialist, Sr. is responsible for assisting Quality Leadership with ensuring compliance, optimizing quality processes, and implanting strategic enhancements of the Quality Management System (QMS) in support of clinical trial operational activities. The Quality Specialist, Sr. will serve as administrator for the quality management software (QMS) and is responsible for development, configuration, and management of the QMS. Please note: this is a fully remote role, with candidates required to be based on the east coast. Responsibilities Supervise and assist in management of QMS Quality Event reporting and related investigation, root cause analysis, proposed corrective and/or preventive measures, and timely closure Leads and project manages QMS activities, ensuring robust implementation and continuous improvement of document control, change control, non-conformance reporting, and supplier qualification/requalification processes within the QMS framework. Communicates with internal team and clients on quality related matters Serves as team lead on QMS-related systems, ensuring compliance with regulatory standards Responsible for QMS metrics and reporting to leaders across the company Trains QMS users on workflow and associated tasks for modules within the QMS Leads configuration, optimization, and continuous improvement initiatives for electronic QMS (eQMS), ensuring alignment with organizational quality objectives and regulatory requirements Identifies and drives QMS-centric Lean and process efficiency initiatives, leveraging data analytics and stakeholder input to enhance system performance and user experience Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses Provide expert-level QMS compliance guidance and strategic quality assurance consultation to internal teams and external partners, ensuring adherence to industry best practices and regulatory expectations. Schedules and conducts monthly quality review meetings as required. Prepare training materials and conduct training for QMS topics. Collaborates with Human Resources regarding training program requirements affected by the QMS. Serves as Quality subject matter expert for configurable systems validation projects. Conducts research and compiles reports. Performs other tasks as defined by the Quality Assurance Leadership Education/Experience 4 -year degree preferred with 5-7 years of Quality Assurance Experience; or a 2-year degree with 8-10 years related experience and/or training; or equivalent combination of education and experience. Must possess strong organizational and interpersonal skills. Experience with QMS platforms such as Veeva is highly preferred. Proven track record of leading QMS implementations or enhancements is a strong asset. Language Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.              Math Ability Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra, statistics, and geometry. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills To perform this job successfully, an individual must have working knowledge of Microsoft Office applications, including word processing software, spreadsheet software, MS PowerPoint, and MS Project. Advanced proficiency in QMS platforms (e.g., Veeva), including configuration, reporting, and user training and experience with eLMS also preferred. Certificates and Licenses Veeva Belt certification preferred. Supervisory Responsibilities This job does not have supervisory responsibilities. Work Environment The noise level in the work environment is usually moderate. Physical Demands While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.