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Quality Assurance Manager

2 months ago

Cheyenne, Wyoming, United States Cardinal Health Full time

At Cardinal Health, we are seeking a Quality Assurance Manager to oversee and enhance our quality systems that support the repackaging of drug products. This role will collaborate with contract repackagers to ensure that repackaged products meet the highest standards of quality and compliance.

The Quality Assurance Manager will be responsible for:

  • Oversight of change control, investigations, complaint investigation, annual product review, retain samples, validation protocols, deviations, non-conformances, and CAPAs.
  • Review and approval of investigations, validation protocols, deviations, and non-conformances for repackager compliance with cGMPs and regulatory requirements.
  • Development of quarterly scorecards to include on-time accountability and quality of expected deliverables/metrics.
  • Approximately 20% travel to include periodic visits to repackagers.

Requirements for this role include:

  • Bachelor's degree in a related field or equivalent work experience.
  • 8-10 years of experience within the pharmaceutical industry, preferably in a quality control or management role.
  • Good knowledge of risk assessment and risk management.
  • Strong working experience with Corrective Action and Preventive Action programs.
  • Excellent hands-on computer skills with thorough knowledge of Microsoft Office, including Excel and PowerPoint.
  • Ability to travel 20%.

This role will manage department operations and supervise professional employees, front-line supervisors, and/or business support staff. The Quality Assurance Manager will participate in the development of policies and procedures to achieve specific goals and interact with subordinates, peers, customers, and suppliers at various management levels.