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Research Quality Assurance GVP Manager

Company: Akebia Therapeutics, Inc.
Location: Cambridge
Posted on: April 6, 2021

Job Description:

Under the direction of the Director--RQA -GVP the Research Quality Assurance Manager--provides administrative support to the Research Quality Assurance activities. Primary duties include: Word Processing-Formatting-Development of Controlled Documents (SOPs, Policies, Forms, Templates, etc.), audit reports, and training presentations; Event Coordination of Audits (internal and external), system access training sessions, general orientation, travel coordination; Administrative Support including filing of essential documents in print and electronic format, review of files for completeness and QC review checklists, maintaining department schedules and trackers for metrics, regulatory inspections and commitments, investigations, etc. Participating in cross training activities to include but not be limited to team projects and shadowing opportunities Required Skills

  • Supports internal staff in the planning and execution of the audit plan, audit coordination, contracting, initiating for training and system access, SOW completion and supports travel coordination
  • Maintains and facilitates the development and update of internal and external audit schedules
  • Track auditor use to assure that assignment leverages auditor experience on the program, ensure that auditor credentials and training are current and filed.
  • Assists management with metrics trending activities and updates to risk-based audit program
  • Facilitates the update to internal quality risk assessments supporting the audit and compliance programs
  • Facilitates searches for changes to regulatory standards and spearheads the initiative for evaluation of internal processes to identify impact and updates
  • Maintains the tracking of inspection commitments and facilitates the tracking of said commitments to completion
  • Maintains the tracking for quality issue investigations and actions
  • Maintains department tracking spreadsheets including metrics and trending, serious breach, and the master inspection spreadsheets
  • Maintains and ensure the archival of department deliverables including but not limited to audit reports, investigations, and associated materials
  • Helps to develop and format internal training materials and presentations, Schedules team training sessions (annual, periodic)
  • Supports, as needed, the preparation, conduct, and follow-up/response, and lessons learned for regulatory agency inspections
  • Acts as the primary liaison to assigned external audit vendors and contractors
  • Develop solutions to a variety of problems. May refer to established precedents and policies
  • Cross trains with senior team members on program compliance support activities related to GLP, GCP, and GVP Required Experience Basic Qualifications:
    • 5+ years of pharmaceutical or healthcare experience and experience working in PV or PV compliance/quality Preferred Qualifications:
      • 2+ years' experience in the pharmaceutical industry
      • Excellent communication and interpersonal skills
      • A self-starter, with tact and diplomacy who is able to define and prioritize tasks within a project
      • Demonstrates good judgement in selecting methods and techniques for obtaining solutions
      • Problem-solving attitude, exhibits judgement and realistic understanding of the issues
      • Excellent computer skills and proficiency including familiarity with Microsoft Office applications including Excel, Word, PowerPoint, MS Project, SharePoint etc.

Keywords: Akebia Therapeutics, Inc., Cambridge , Research Quality Assurance GVP Manager, Executive , Cambridge, Massachusetts

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