Quality Assurance Manager

2 weeks ago

Indianapolis, Indiana, United States Cardinal Health Full time

Job Summary

Cardinal Health is seeking a Quality Assurance Manager to oversee and enhance the 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.

Responsibilities

  • Collaborate with contract repackager's management team and other business teams to develop systems, validations, and procedures that effectively integrate repackaged products.
  • Responsible for oversight of change control, investigations, complaint investigation, annual product review, retain samples, validation protocols, deviations, non-conformances and CAPAs.
  • Review and approve investigations, validation protocols, deviations, and non-conformances for repackager compliance with cGMP's and regulatory requirements.
  • Develop quarterly scorecard, to include on time accountability and quality of expected deliverables/metrics.
  • Position will require approximately 20% travel, to include periodic visits to the repackagers.

Qualifications

  • Bachelor's degree in related field, or equivalent work experience, preferred.
  • 8-10 years of experience within the pharmaceutical industry preferred.
  • 5+ years of experience as a Manager performing Quality Control in a pharmaceutical manufacturing or packaging environment preferred with an emphasis on solid oral and oral liquid unit dose preferred.
  • Effective problem solving and analytical skills able to lead and influence others to drive improvements.
  • Good knowledge in risk assessment and risk management.
  • Strong working experience Corrective Action and Preventive Action programs.
  • Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Excel and Power Point (statistics, graphing, presentations, etc.).
  • Excellent verbal and written communication skills.
  • Ability to travel 20%.

What is expected of you and others at this level

  • Manages department operations and supervises professional employees, front line supervisors and/or business support staff.
  • Participates in the development of policies and procedures to achieve specific goals.
  • Ensures employees operate within guidelines.
  • Decisions have a short term impact on work processes, outcomes and customers.
  • Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management.
  • Interactions normally involve resolution of issues related to operations and/or projects.
  • Gains consensus from various parties involved.

Benefits

  • Medical, dental and vision coverage.
  • Paid time off plan.
  • Health savings account (HSA).
  • 401k savings plan.
  • Access to wages before pay day with myFlexPay.
  • Flexible spending accounts (FSAs).
  • Short- and long-term disability coverage.
  • Work-Life resources.
  • Paid parental leave.
  • Healthy lifestyle programs.

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