Sr. Quality Systems Specialist

Our clinical-stage Vaccine Client here in Boston, MA is growing and looking to add a Sr. Quality Systems Specialist to their team! This role will provide support and expertise on quality systems applications, procedures, and operational activities under general supervision. 

Role will also be responsible for document management, learning management, change control coordination, deviation investigation/root cause analysis, corrective and preventive action (CAPA) administration, supplier qualification coordination, inspection readiness, electronic system implementation, process document authoring, training material development/delivery, and metrics generation/communication. 


  • Perform as Senior Document/Training Specialist including:
    • Routing and coordinating controlled documents for creation, revision, and obsoletion
    • Routing, documenting, and tracking GxP training activities including departmental curricula and individual training plans/matrices
    • Providing primary Customer Service point of contact for technical questions relating to the Quality systems and related processes
    • Notifying staff of new, revised, or obsolete controlled documents or training assignments
    • Maintaining training records
    • Generating metrics and reports
    • Document formatting
    • Biennial (periodic) document review support and reporting
  • Coordinate Quality Systems Processes
    • Change Control
    • Investigations
    • Corrective/Preventive Actions (CAPA)
    • GxP Supplier Qualification
    • Internal and external inspections and audits, including inspection readiness activities.
  • Support Electronic Systems Implementation/Rollout and Updates
    • Coordinate with line manager for development, continuous improvement efforts, and on-going maintenance of Quality e-Systems including, but not limited to, Document Management, Deviation, CAPA, Change Control, Quality Risk Management, and Learning Management
    • Liaise with IT technical team and vendors throughout development to ensure business defined acceptance criteria is achieved for all system changes and projects
    • Support development of system fixes, enhancements, and upgrades – including developing user requirements
    • Support risk assessment execution for implementations, fixes, enhancements, and system upgrades
    • Ensure high levels of system availability/functionality through effective testing – including user acceptance test script development and test execution
  • Support Quality Systems & Compliance Continuous Improvement
    • Support development of streamlined processes and supplemental documents (including procedural document creation or maintenance) governing management and usage of Quality Systems
    • Assist in the development and delivery of training for Quality Systems
    • Maintain and distribute QMS related metrics
    • Drive Quality Systems data quality improvements
    • Support customer forums with the areas/departments detailing updates, opportunities, obstacles, etc. regarding the systems/processes
    • Interface with other functions to communicate best practices and identify / improve awareness and adoption of Quality systems and processes
    • Support CAPAs stemming from audits, inspections, deviations and other Quality related assessments, as well as actions stemming from Change Controls
    • Support audit preparations with respect to Quality Systems
    • Own investigation of deviations and CAPAs related to Quality Systems
    • Support change controls related to Quality Systems


  • Bachelor’s degree in scientific discipline/Life Sciences preferred or equivalent experience in biotech or pharmaceutical industry
    • 3-5 years’ experience in GxP roles.
    • Experience with biologics/vaccines is preferred
  • Excellent computer skills and advanced knowledge of Quality Systems.  Direct experience with Quality Management Systems, Document Management Systems, and Learning Management Systems
    • Veeva Systems experience preferred
  • Quality e-system implementation/roll out experience – working with suppliers, system development, training delivery, and user acceptance testing
  • Change Control execution and coordination experience
  • Statistical reporting capabilities – metrics, key performance indicators and trending
  • Proficient with Microsoft Office applications, Adobe, and document management templates
  • Smartsheet experience a plus.
  • Formal or technical writing experience
  • General knowledge of regulatory requirements for the pharmaceutical, biotechnology or vaccine industry required
  • Advanced knowledge of global quality system requirements