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Director, Corporate Compliance - Quality Document Management - United States  

Company managed [?] Still accepting applications

Posted on : 03 July 2017

Project Description

About Us:
  • Our company  is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. 
  • The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors..
  • We are seeking a highly motivated individual to join us as a Director, Corporate Compliance - Quality Document Management. 
  •  You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.

 
Responsibilities:
Develop, implement, and manage the company corporate-wide document management program and processes, including:
  • Controlled document processing, issuance, and change control 
  • Document storage and archiving 
  • Record retention program 
  • Good documentation practices 
  • Electronic records and data management 
  • Management of document templates 
  • Lead corporate-wide cross-functional team to assess, develop and implement document management systems and processes
  • Implement a standard document management system and process across all functions and sites to achieve consistency and scalability 
  • Implement and manage electronic document management systems (e.g., controlled document processing, deviation/CAPA management) 
  • Ensure Part 11 compliance for electronic systems Periodically assess compliance to document management program requirements and procedures within company sites and Contract GxP organizations 
  • Ability to travel up to 15% Perform other duties as assigned.


Requirements:                             
  • Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in document management in the pharmaceutical industry 
  • Experience with GxP document management 
  • Experience with GxP IT systems 
  • Experience with direct US and international health authority inspections and interactions 
  • Proficient in MS Word, Excel, and Power Point 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment 
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities 
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. 
  • Proven ability to develop and lead a cross-functional and cross-site team.