16 days old

Clinical Research Quality Assurance Director

Total Clinical Trial Management
  • Job Type
  • Job Status
    Full Time

Job Summary:

The Quality Assurance Director manages all aspects of Quality Assurance relating to human resource and operational objectives, including development of QA and quality improvement plans, validating quality processes, and preparing quality documentation reports, among other matters.

Major Responsibilities:

  • Accomplishes quality assurance human resource objectives by:
    • Orienting, training and coaching employees;
    • Communicating job expectations;
    • Planning, monitoring, appraising and reviewing job contributions of QA; and
    • Enforcing policies and procedures.
  • Achieves quality assurance operational objectives by:
    • Contributing information and analysis to strategic plans and reviews;
    • Preparing and completing action plans;
    • Implementing production, productivity, quality and customer-service standards;
    • Identifying and resolving problems;
    • Completing audits;
    • Determining system requirements; and
    • Implementing change.
  • Develops quality assurance plans by:
    • Identifying critical control points and preventive measures;
    • Establishing critical limits, monitoring procedures, corrective actions and verification procedures; and
    • Monitoring inventories.
  • Validates quality processes by:
    • Establishing product specifications and quality attributes;
    • Measuring production;
    • Documenting evidence;
    • Determining operational and performance qualification; and
    • Writing and updating quality assurance procedures.
  • Maintains and improves quality by:
    • Completing company, system, compliance and clinical site audits; and
    • Collaborating with other members of management to develop new training methods.
  • Prepares quality documentation and report by:Updates job knowledge by:
    • Collecting, analyzing and summarizing information and trends including failed processes, corrective actions and re-validations.
    • Studying trends in and developments in quality management;
    • Participating in educational opportunities;
    • Reading professional publications;
    • Maintaining personal networks; and
    • Participating in professional organizations.
    • Enhances department and organization reputation by:
      • Accepting ownership for accomplishing new and different requests; and
      • Exploring opportunities to add value to job accomplishments.



  • Bachelor’s degree; Master’s preferred
  • Excellent oral and written communication, organizational and planning skills
  • Detail-oriented, thoroughness and dealing with complexity
  • Willing and able to travel up to 20%
  • A minimum of 5 years of experience in quality assurance management


Posted: 2019-01-04 Expires: 2019-02-04

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Clinical Research Quality Assurance Director

Total Clinical Trial Management

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