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Senior Quality Manager

  • Location: Boston
  • Salary: US$60.00 - US$75.00 per hour per hour
  • Job Type:Contract

Posted about 1 month ago

  • Sector: United States
  • Contact: April Hazlett
  • Duration: 6 months
  • Expiry Date: 30 June 2022
  • Job Ref: JN -052022-470624

Key Responsibilities:

  • Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation, consultation, and other supportive services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated.
  • Maintains a contemporary knowledge of current industry trends, standards, and methodologies as it relates to Good Clinical Practice (GCP).
  • Liaise with Vertex clinical functions and external parties including CROs, Vendors and investigator sites to promote high level of quality and consistency across and within programs.
  • Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with study team in development of risk mitigation strategies.

Minimum qualifications:

  • M.S. (or equivalent degree) and 7+ years of relevant work experience, or B.S. and 10+ years of relevant GCP work experience
  • Maintain contemporary knowledge and awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.)
  • Experience with all phases of clinical trial development involving drugs, biologics, devices and drug/ device combinations.
  • Device experience preferred but not required
  • Working knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
  • Ability to understand and translate customer needs for innovation and creative approaches to quality management
  • Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers.
  • Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
  • Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
  • Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint, Visio).