Principal Supplier Quality Auditor

4 days ago

Shanghai, Shanghai, China Cardinal Health Full time

Job Summary

We are seeking a highly skilled Principal Supplier Quality Auditor to join our team at Cardinal Health. As a key member of our Quality & Regulatory Audit team, you will be responsible for assessing processes and practices for regulatory risk and conformance to quality standards.

Key Responsibilities

  • Conduct thorough audits of assigned suppliers to ensure compliance with regulatory requirements and quality standards.
  • Develop and implement audit plans to identify areas for improvement and ensure effective corrective actions.
  • Collaborate with business leaders to implement improvements and ensure regulatory compliance.
  • Manage internal corrective actions in response to audit findings to ensure effectiveness and avoid repeat issues.
  • Identify and propose audit program enhancements to improve overall quality and regulatory compliance.
  • Ensure compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation.
  • Communicate best practices observed to other business units.
  • Prepare for audits by researching materials, standards, policies, and procedures to formulate a plan of action.
  • Lead the escalation process for unacceptable audits to appropriate management representatives.

Requirements

  • Apply comprehensive knowledge of regulatory requirements, including MDD, EU-MDR, ISO Quality Management Systems, Pharmaceutical guidelines, FDA, cGMP, MDSAP, and Risk Management.
  • Knowledge of business platforms and processes, such as Veeva Vault, SAP, BPCS, and Agile PLM.
  • Ability to multi-task and work in a high-paced environment with an awareness of continued impact on compliance and operational performance.
  • Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans.
  • Excellent written and verbal communication skills to drive clear alignment of company and department goals.
  • The ability to take responsibility for the professional development of you and your colleagues.
  • Commitment to work within the ethos of the company mission, code of conduct, and applicable legal standards/regulations.

Qualifications

  • Bachelor's degree in a related field or equivalent work experience.
  • 4+ years of experience in a related field, preferably in Quality System audits in the Medical Device or other regulated industry.
  • Current knowledge of GMP auditing & regulation (FDA 21 CFR 820 & 21 CFR 210/211, & ISO13485) & international quality system requirements.
  • Language skills: ability to read, analyze, and interpret quality system documents, records, and technical procedures.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information to groups of managers, clients, and the general public.
  • Certificates, Licenses, Registrations: Certified Quality Auditor (CQA) to ASQ CBA, ASQ CQA, or ISO Lead Auditor training by an accredited organization and/or Certified Quality Engineer (CQE) strongly preferred.
  • Up to 50%-70% of travel required.

What We Offer

  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.
  • The chance to work with a leading healthcare company.

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