Senior Quality Assurance Manager

6 days ago

Durham, North Carolina, United States 5PY US Quintiles, Inc. Full time
Job Overview:

As a Senior Quality Assurance Manager, you will oversee and coordinate assigned QA programs in support of customer accounts, functional accounts, audit and inspection programs, or QA quality management systems at a regional and/or global level.

Key Responsibilities:
  • Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed
  • Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
  • Oversee and participate in the documentation, reporting, and closure of compliance issues
  • Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP, etc.
  • Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified
  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
  • Serve as author of Quality Assurance Standard Operating Procedures (SOPs) as assigned
  • Advise Quality Assurance management on system audit needs
  • Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment, and audit reporting and/or follow-up status
Qualifications:
  • Bachelor's Degree
  • 7 years Quality Assurance experience in pharmaceutical, technical, or related area. Equivalent combination of education, training, and experience
  • Knowledge of word-processing, spreadsheet, and database applications
  • Extensive knowledge of pharmaceutical research and development processes and regulatory environments
  • Considerable knowledge of quality assurance processes and procedures
  • Strong interpersonal skills
  • Excellent problem-solving, risk analysis, and negotiation skills
  • Exceptional training capabilities
  • Effective organization, communication, team orientation, and leadership skills
  • Ability to work independently with initiative
  • Ability to manage multiple projects
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients
About IQVIA:

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://www.iqvia.com/

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