Quality Assurance Manager

The Quality Assurance Manager 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:
    • Collecting, analyzing and summarizing information and trends including failed processes, corrective actions and re-validations.
  • Updates job knowledge by:
    • 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.

Qualifications:

  • Bachelor’s degree; Master’s preferred
  • Excellent oral and written communication, organizational and planning skills
  • Strong understanding of GCP/ICH guidelines
  • Detail-oriented, thoroughness and proficient at dealing with complexity
  • Willing and able to travel up to 20%
  • A minimum of 5 years of experience in quality assurance management in a clinical research setting
To apply, please send a copy of your resume/cover letter to info@totalcro.com with Assistant Project Manager as the subject