Lead Auditor, Quality Compliance

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SUMMARY

The Lead Auditor, Quality Compliance will form part of the Corporate Audit team and will lead, coordinate and perform corporate audits of the Quality Management System (QMS) as part of Integra Life Science's quality internal audit program across more than 15 design, manufacturing, and distribution facilities and a diverse portfolio of leading medical devices. Ensure that the corporate audit policy/procedures are fully implemented on audits conducted for which s/he is responsible, working alone or leading a multi-skilled team of auditors drawn across the company.

All audits shall be performed in compliance with recognized ISO, GMP, GDP, GCP, and GLP, global policies/procedures and corporate auditing requirements, as applicable. Their principal function is to lead, coordinate, physically perform and be responsible for the audits assigned to him/her personally as part of the annual corporate audit schedule, utilizing the support and resources provided by the rest of the corporate audit team and liaising with site Quality representatives until the assignment is completed.

Subsidiary functions would include the technical assessment of proposed compliance actions (CAPAs) for acceptability, evaluation of completed self-certification and audit questionnaires and judging the compliance status of the facilities audited. Directly assigned audits (as applicable) as per the Audit Schedule and completes them. This remit also includes the planning, coordination, logistics, execution and follow-up of the audit. In his/her subsidiary role as a Subject Matter Expert (SME), will provide internal consultancy on his/her specific area of expertise to the audit team in particular as well as to the organization in general, and assisting team leadership with improving audit standards, inspection readiness, SME coaching, and reviewing company policies in this subject area.

The incumbent will possess extensive GMP audit experience and practical skills including: the ability to write objective technical audit reports, evaluate and make objective judgments on technical issues arising during the audit, utilize multi-cultural sensitivity while driving audits forward consistently and on time, as well as project and time management. His/her mix of objectivity, experience, qualifications, technical expertise, pragmatism as well as interpersonal and communication skills should create instant credibility with auditees and senior management while helping deliver the audit program's targets on-time and to-budget.

RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

* Obtain satisfaction through evidence-based investigation techniques that the global QMS policies and standards, the global policies and procedures and the regulatory and legislator requirements are being complied with consistently and to the required level.

* Supply, in an agreed written format, a formal report to the head of the audit program on the conduct of each site audit, describing the way the audit was conducted, the context and a categorized list of audit observations and recommendations made during the audit, an overall site classification for the site and an executive summary designed to be communicated to the heads of Global Quality, Supply Chain, Regulatory Affairs, Product Development, and business leaders as required or applicable.

* Identify problematic areas of site and quality system operations during the audit and assist the site representatives during, and following, the audit with assistance, suggestions and recommendations for the site to reach the desired level of improvement.

* Support site inspection readiness through formal corporate audits as well as informal high-risk CAPA reviews, mock…