QA Manager, Documentation & Training found on Fusion Pharmaceuticals

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Employing its platform technology, including proprietary Fast-Clear linker, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is growing a pipeline of precision oncology therapies in development, and recently announced a collaboration agreement with AstraZeneca. Following Fusion's June 2020 IPO, the Company has cash to fund operations into 2024.

Position Summary

Fusion has opened a newly created role in Quality Assurance for a Manager, Documentation & Training. The successful candidate will proactively manage controlled documentation related to GxP activities, along with administration of the Global training program. This role will act as acting as in-house expert to internal and external parties. This role will report to the Head of Quality Assurance.

Key Responsibilities

• Independently manage and monitor the processing, review, and approval of all controlled documents in both electronic document management systems (EDMS) and supporting manual systems
• Coordinate the development and revision process of Standard Operating Procedures (SOPs), forms, and other controlled documents assuring that the corporate and regulatory standards are upheld
• Manage the daily flow and final release of controlled documents through the document management system
• Continuous improvement of the Document Management program
• Participates in the development and roll-out of document management tools, monitors documentation/Quality Systems function, and coordinates with IT on issues
• Provide user assistance and training on the EDMS and Learning Management Systems (LMS)
• Develops and delivers training regarding document control processes and system changes
• Ensure compliance with controlled document format and content
• Maintain master documents and records (both hardcopy and/or electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized
• Manage the document periodic review process
• Responsible for managing record retention policies and procedures
• Track and communicate company training compliance within multiple departments
• Assist with the development of evolving document and learning management systems
• Maintain SOP, change control, deviation, CAPA, etc. logs contemporaneously
• Assist with generating Quality Document Management metrics as needed
• Represent quality in departmental or team meetings
• Assist Quality Management by performing various tasks in support of the administration and maintenance of Quality Systems
• Represent Quality Assurance as the Subject Matter Expert (SME) for Good Documentation Practices

Required Qualifications

• Bachelor's degree, Life Sciences preferred, but not required
• Experience in Document Management System and network-based Quality Management Systems
• Worked in an FDA regulated environment and familiar with Health Authority regulations and guidance
• Minimum of five (5) years QA document management experience
• Proficient in document management systems
• Highly Proficient in Word, Excel, and PowerPoint Smartsheet and SharePoint are a plus
• Ability to work effectively on multiple projects simultaneously with minimum supervision
• Strong interpersonal and communication skills
• Able to organize and prioritize work
• Strong written and verbal communication skills
• Effective/concise communicator with management and internal teams
• Experience with working in startup environments moving in rapid growth/manufacturing
• We are open to candidates in the Boston and Hamilton, Ontario area
• Travel required less than 5%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.