Octapharma - Charlotte, NC

posted 3 days ago

Full-time - Mid Level
Charlotte, NC
Ambulatory Health Care Services

About the position

The Veeva Quality System Manager at Octapharma Plasma is responsible for managing and maintaining the Veeva Quality Management System (QMS) application, ensuring its performance and availability. This role involves data analysis, quality assurance monitoring, regulatory compliance, and process improvement, all aimed at enhancing product quality and safety in the plasma collection and processing environment.

Responsibilities

  • Manage and maintain the Veeva Quality Management System (QMS) application.
  • Lead the configuration of the Veeva QMS software to meet business needs.
  • Provide technical support and training content for end users.
  • Troubleshoot Veeva QMS to resolve technical issues.
  • Coordinate and implement software updates and upgrades in collaboration with IT departments.
  • Analyze data from various sources to identify trends and areas for improvement.
  • Develop and maintain dashboards, reports, and data visualizations.
  • Monitor key quality metrics related to plasma collection and processing.
  • Perform root cause analysis on quality incidents and recommend corrective actions.
  • Support the preparation of regulatory submissions and audits.
  • Ensure compliance with FDA regulations and internal policies.
  • Identify opportunities for process optimization within the quality assurance framework.
  • Collaborate with cross-functional teams to implement data-driven solutions.
  • Communicate findings, risks, and recommendations to management.
  • Provide training and support on data analysis tools.

Requirements

  • Bachelor's degree in data science, Statistics, Computer Science, or a related field required.
  • Minimum of 2-4 years of experience in data analysis or administering software applications.
  • Proficiency in data analysis tools (e.g., Excel) and data visualization software (e.g., Tableau, Power BI).
  • Familiarity with cGMP guidelines for the management of a QMS application required.
  • Strong problem-solving abilities with attention to detail.
  • Excellent verbal and written communication skills.

Nice-to-haves

  • Experience with statistical analysis and quality control methodologies (e.g., Lean Six Sigma) is preferred.
  • Ability to work effectively in a collaborative, cross-functional team environment.

Benefits

  • Formal training
  • Outstanding plans for medical, dental, and vision insurance
  • Health savings account (HSA)
  • Employee assistance program (EAP)
  • Wellness program
  • 401 (k) retirement plan
  • Paid time off
  • Company-paid holidays
  • Personal time
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