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Document Control Manager

Company: Precision BioSciences
Location: Durham
Posted on: August 16, 2019

Job Description:

The Document ControlManager, within the Quality and Compliance Team, will report to the Sr. Director of Quality and Compliance. The Document Control Manager will help to develop and maintain the Quality Management System through the development, implementation, maintenance and management of quality systems, quality standards, policies and procedures. This person will work within the Quality team to ensure compliance with FDA and other regulatory agency requirements, as well as customer and internal company quality systems requirements.Essential Duties and Responsibilities

  • Develop, implement, maintain and manage phase-appropriate Quality Management System (QMS) through the development, review, approval, and tracking of documentation including policies and standard operating procedures (SOPs)
  • Create, revise, review and approve documentation in Quality Assurance operations, including master batch records, protocols, change control, deviations, CAPAs, specifications, and incoming goods disposition
  • Perform internal and external audits independently, including planning, execution, report writing / issuance and CAPA approval / follow-up
  • Understand and interpret regulatory requirements and guidelines to ensure company compliance and to maintain certification with regulatory authorities
  • Act as primary representative on project teams, as assigned
  • Train new staff in quality system requirements and applicable regulations
  • Complete other projects and tasks, where applicable
  • Supervise staff in the completion of Quality Assurance tasks
  • Be an example of Precisions Core Values, throughout the work performed and decisions made, leading by example
  • Proactively raise issues and concerns, while bringing solutions to the table whenever possible
  • Be a champion of change, supporting company decisions, helping teams to understand decisions made even if they feel differently
  • Partner with HR on their teams performance management (corrective actions, PIPs, terminations, performance reviews), professional development, employee relations, keeping up to date and communicating company policies and expectations
  • Participate and support company events (speaking, presenting, meetings, trainings, etc.) Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Education/Experience
    • BS or equivalent in life science or related field with 10+ years industry experience in GMP, GLP and/or GCP Quality Assurance Required:
      • Knowledge of FDA regulations and standards, especially those pertaining to the production of biological products
      • Experience with electronic quality management system administration Preferred:
        • Previous people leadership experience strongly preferred Travel Requirements
          • This position requires travel up to 10%. Location
            • This position is located at the main headquarters in Durham, NC and is required to physically be and work in the office in order to be most effective, at the discretion of the manager. Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Keywords: Precision BioSciences, Durham , Document Control Manager, Executive , Durham, North Carolina

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