Philips Senior Compliance Auditor in Shanghai, China

Job Summary

Responsible for performing timely, detailed, and independent internal Good Clinical Practices (GCP) and Quality Management System (QMS) audits to assess regulatory compliance to applicable local and international regulations/standards and Philips Healthcare requirements.

Clinical Audits shall be performed in accordance with applicable standards and regulations. The focus of the audit is compliance to clinical research regulations specific to the country in which the research is conducted. For example, audits in the U.S. shall assess compliance to 21 CFR Part 812, 50, 54, 56 (U.S. GCP regulations), as well as Part 11 (as applicable), and HIPAA. Audits in China shall assess compliance to CFDA Decree No.25. Audits in Europe shall assess compliance to ISO 14155 if the data are to be used only in the EU. (Note: If the data from research conducted in a country outside the U.S. will be used to support a submission to FDA, the audit scope should also include U.S. GCP regulations.) Clinical research must also meet any local requirements (e.g. state laws). Clinical audits also determine the extent of compliance with Philips clinical study procedures, protocol and policies.

Knowledge & Critical Experiences

  • BS/BA plus a minimum of 10 years’ experience in a medical device or regulated industry

  • Certified Lead Auditor; or ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA); or Certification with a recognized Accreditation body (i.e. RAB-QSA / IRCA)

  • In-depth knowledge of FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282)

  • In-depth knowledge or experience of medical device regulatory requirements related to:

  • Medical devices Reports of Corrections and Removals (21 CFR 806)

  • Medical Device Reporting (21 CFR 803)

  • Risk Management (ISO 14971)

  • Working knowledge of appropriate global medical device regulations, standards, and requirements including: ISO 9001, MHLW Ord.169, ANVISA, IEC 62304, IEC 60601-1

  • Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA)

  • Auditors shall have the necessary education, background, training and experience in order to independently lead and conduct the clinical research audit. Qualification consists of the following (with appropriate evidence, certification documentation or training record required):

  • At least one of the following:

  • Current certification with a recognized Accreditation body (i.e. RAB-QSA / IRCA);

  • Successful completion of: ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA);

  • Successful completion of:

  • A recognized Lead Auditor Course

  • All the following:

  • Training to U.S. Good Clinical Practice Regulations (21 CFR Part 812, 50, 54, 56) as well as Part 11 and HIPAA;

  • Training to ISO 14155 and ICH E6;

  • Training to 21 CFR Part 820 and ISO 13485;

  • Five or more years working in the area of quality or regulatory assurance for a regulated industry;

  • Five or more years conducting good clinical practice (GCP) audits

  • Training to CFDA Decree No.25

Key Area of Responsibility

  • Plan, coordinate, and execute QMS audits as Lead Auditor or Auditor, to assess the compliance and effectiveness of the overall QMS of the Philips Healthcare organizational unit(s) being audited.

  • Review responses to audit findings for completeness and effectiveness.

  • Identify and share “Best Practices” within Philips.

  • Participate in PH Quality & Regulatory initiatives as a cross functional contributor.

  • Provide audit coaching/readiness training, and support for external audits

Competencies

  • Strong business acumen, including understanding of linkages between processes, risks and controls

  • Presentation of results in a logical and clear manner

  • Ability to analyze information and come to conclusions based on presented data

  • Ability to communicate effectively both orally and in writing

  • Strong organizational and interpersonal skills

  • Manage time working on multiple projects simultaneous

  • Open to other’s ideas and work collaboratively across functions.

KPI:

Plan, conduct and report internal audits according to predetermined schedule and within procedural timeframes. Prepare and present timely summaries of internal audit results to various levels of Philips Healthcare management. Facilitate effective corrective/preventive actions. Ensure audit nonconformances are addressed in a timely manner Develop a thorough understanding of the complex PH organizational structure, functions, processes, and tools. Actively promote a quality and regulatory compliance culture within Philips Healthcare by creating an environment, in which open discussion and reporting of concerns is promoted and encouraged (lead by example!).

Key Challenges:

Challenges:

Ability to manage organizational conflict by identifying compliance issues based on factual information and knowledge of the regulation. The governmental regulations (in particular, the USA interpretations by the FDA) need to be applied with rigor to ensure compliance.

Complexity:

  • Identifying compliance issues in lieu of external regulators while at the same time understanding the level of risk/business impact (concentration given to higher risk issues rather than lower risk)

  • Developing a thorough understanding of the complex PH organizational structure, functions, processes, and tools to enable valid findings