QA Manager, Documentation & Training

Fusion

Posted on: February 22, 2021

Closing: March 24, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

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.

Fusion

Posted on: February 22, 2021

Closing: March 24, 2021

Salary($): Undisclosed

Position Type: Full Time

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Career Focus: Quality

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