Senior Principal Auditor, Corporate Quality

What Quality & Regulatory Audit contributes to Cardinal Health

Quality & Regulatory Audit is responsible for assessing processes and practices for regulatory risk and conformance to quality standards, and working with business and quality leaders to implement improvements.

  • Demonstrates comprehensive knowledge of regulatory requirements in their respective areas, as well as auditing techniques.
  • Analyzes regulatory requirements and overall program compliance to determine enterprise risk.
  • Proposes and/or implements audit program enhancements.
  • Ensures compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation.
  • Communicates best practices observed to other business units.
  • Prepares for audits by researching materials, standards, policies and procedures to formulate a plan of action.

Accountabilities

  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
  • Participates in the development of policies and procedures to achieve specific goals
  • Recommends new practices, processes, metrics, or models
  • Works on or may lead complex projects of large scope
  • Projects may have significant and long-term impact
  • Provides solutions which may set precedent
  • Independently determines method for completion of new projects
  • Receives guidance on overall project objectives
  • Acts as a mentor to less experienced colleagues

Qualifications

  • Bachelors in related field, or equivalent work experience, preferred
  • 8+ year’s experience in related field, preferred
  • Excellent communication skills required (speaking/writing)
  • American Society of Quality (ASQ) Certified Quality Auditor (CQA) certification, or equivalent, preferred
  • Willing to do extensive traveling (both Domestic and International) around 60 % of the time is expected
  • Deep knowledge in Medical Device area (CFR 820, ISO13485:2016, and MDSAP)
  • Knowledge in Design Control and Risk Management processes
  • Must live close to an International Airport
  • GMP auditing experience in areas like Pharma or Nuclear Medicine or Distribution preferred
  • Knowledge of a secondary language (e.g. Spanish, German, Thai, or Malay) is a plus
  • Knowledge of SmartSolve or similar auditing electronic system is a plus