BrightOwl Loader Loading

Manager, Quality Systems Document Control - United States  

Company managed [?] Still accepting applications

Posted on : 11 June 2017

Project Description

Description:
  • 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 Quality Systems Document Control Manager. 
  • Develop and implement quality systems associated with Document Management with a focus on batch record and label issuance. 
  • Work closely with SMEs to create and implement workflows and business processes that align with best practices that ensure right first time. 

 

Responsibilities (include but are not limited to):
  • Establish and maintain a document management system compliant with regulatory, quality, and company requirements. 
  • Responsible for the creation and management of all documentation and records issuance and archival processes to support clinical and commercial manufacturing. 
  • Provides guidance and advice on methods, procedures, standardization and requirements associated with the document management system. 
  • Responsible for maintaining the document change control system. 
  • Manages the document change process so that only approved and validated changes are incorporated into effective product and process documentation. 
  • Ensures accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems. 
  • Collaborates with cross-functional departments to ensure timely implementation of document change requests. 
  • Support audits (internal, external) in order to verify that regulatory and quality requirements have been met. 
  • Provide work direction and guidance to staff to assure completion of assigned tasks and other duties. 
  • Responsible for procedure reviews and facilitating procedure updates with process/system owners. 
  • Assure that personnel are adequately trained in the principals, policies, and procedures of the document management system. 
  • Perform other duties as required. 
 


Requirements:
  • Bachelor’s Degree. 
  • Minimum 8+ years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems. 
  • Minimum 3+ years of supervising staff. 
  • Strong knowledge of GMP, SOPs and quality system processes.   
  • Excellent organizational skills and ability to review and update processes or procedures. 
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, documentum, Veeva or equivalent). 
  • Strong written and verbal communication skills. 
  • Ability to communicate and work independently with scientific/technical personnel. 
  • Experience in pharmaceutical or bio-pharmaceutical field. 
  • Education or training in cell culture and gene therapy manufacturing environment a plus. 
  • Proficient in drafting and completing technical documents and presentations. 
  • Quality systems demonstrated knowledge in areas such as document management, document change control audits, batch record and label issuance. 
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).  
  • The standard work week for this position is Tuesday – Saturday or Sunday -Thursday.