Quality Manager

Cardinal Health has partnered with a Global leader in Specialty Medicine, to launch a new drug into the US market.  The Quality Assurance Manager is the head of the Quality Assurance team in our Indianapolis manufacturing facility.  They are responsible for ensuring release of the final product in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements.

Accountabilities in this role:

  • Responsible for the release of final product before distribution to the market, including submission (by ensuring preparation of the adequate documentation) of the product.
  • Manages deviations related to final product packaging components and/or raw materials disposition (e.g. root cause analysis, CAPA plan identification and follow-up) in a timely manner
  • Ensures CAPAs for which the team is responsible are followed and closed within defined timelines 
  • Must be able to approve temporary deviations but understanding the nature of the deviation content including intermediate steps and make the link with the final product and any regulatory requirement
  • Reviews, comments and challenges in an appropriate way, the Product Quality Reviews for the product with the team’s responsibility.  In that context, has the knowledge of the production process of the product
  • Understands technical/release product issue and evaluate their potential impact on product quality and compliance
  • Escalates complex issues to management in a timely manner
  • Responsible to manage a small team of employees
  • Prioritizes and ensures work is delivered in an efficient way
  • Provides daily problem solving
  • Represents QA in meeting related to his/her area of responsibility (product tree meeting, deviations, change control, stability planning and review, validations, etc.)
  • Performs other duties as assigned


  • B.S. degree in Chemistry, Biology, or related science field.
  • 5+ years of relevant work experience in Quality Assurance, working with 21 CFR 210 and 211 and external Regulatory body regulations. 
  • Strong leadership skills with ability to prioritize and deliver on multiple concurrent initiatives that have significant impact
  • Experience leading regulatory inspections is preferred. 
  • ASQ Certification preferred
  • Must work well with others and understand how to be successful in a Team environment.
  • Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated.
  • Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills. 
  • Position is based out of Indianapolis, Indiana

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.