Documentation & Training Manager, Quality Systems

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Documentation & Training Manager, Quality Systems

This position will be responsible for managing and archiving GXP regulated documentation through review and quality control procedures. This position creates and oversees document workflows in VEEVA, AVROBIO’s electronic document management system to ensure documents are appropriately reviewed and approved. This position designs, supports, monitors, and improves the Learning Management System. This role will also generate and maintain compliance and metrics reporting that include documentation and training KPIs.

Cambridge
Quality
Jun 9 2021
Key Responsibilities
  • Train and support stakeholders in routing GXP (e.g., GMP / CMC documents) documents through VEEVA, AVROBIO’s validated electronic document management system, document repository, and learning management system
  • Perform reviews and quality control activities of procedural documents and other controlled GXP regulated documents. Ensure correct templates and formatting are utilized for GXP controlled document types.
  • Proactively builds, facilitates, and coordinates role-based curricula to support end-user trainings.
  • Monitor workflows and training records to ensure users complete tasks in a timely manner
  • Perform archival duties as defined by 21 CFR Part 58, 210, 211, and other regulations
  • Work as a VEEVA subject matter expert, troubleshooting technical issues identified during document processing in the document management system
  • Participate in inspection readiness and inspection support activities, leading document retrieval actions
  • Compile and provide applicable metrics related to document processing and for periodic Quality Management Review meetings
  • Conducts internal audits of the electronic document management and learning management system and documents where needed to ensure compliance to applicable policies and SOPs
  • Promote a Quality Culture by supporting innovation, teamwork and efficiency within the organization
Minimum Requirements/ Qualifications
  • Undergraduate degree (BA/BS) in Scientific discipline/Life Sciences or similar.
  • Minimum 4-7 years of experience in pharmaceutical / biopharmaceutical industry document control. Experience with electronic document management and learning management systems is required.
  • Sound knowledge of cGMP standards and documentation
  • Excellent skills within MS Word and Office suite
  • Excellent verbal and written communication skills to communicate effectively
  • Strong organizational skills, attention to detail, and knowledge/experience with electronic data management
  • Experience implementing and administering Veeva Vault Quality or other VEEVA modules is a plus
  • Experience with Regulatory documentation and Regulatory submissions is a plus
  • Ability to manage multiple tasks in parallel
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer