Lead Auditor, Quality Compliance

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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 LifeScience’s quality internal audit program across more than 15 design, manufacturing, and distribution facilities and a diverse portfolio of leading medical devices.

Responsibilities:

• 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 inspection role-playing and SME / auditee coaching and feedback.
• Work with the head of the audit program to identify areas of improvement in terms of efficiency and efficacy of the corporate audit processes and systems whilst retaining the same levels of quality control.
• Facilitate Global implementation of policies at the divisional, site and third-party representative level by clear and consistent application of a mix of auditing, education, communication and enforcement that quickly escalate or drive down potential issues within the organization.
• Lead or physically participate in, the required number of corporate audits and work with Site Quality Representatives to quickly finalize the reports within the standard timelines.
• Recommend to the head of the audit program any additional work required with the audited sites such as follow-up or re-audits and participate in any continuous improvement or quality initiatives as a representative of Global quality organization.
• Provide review and support to individuals, working groups or sites within the company or approved suppliers outside the company on the specific technical area of expertise.
• Continue to develop and expand own personal skills, specific professional and technical expertise and technical auditing knowledge as far as personal ambition and ability will support it, whilst staying within the general scope of this job description.
• Support a quality culture of continuous improvements and foster collaboration with cross-functional groups and sites.
• Demonstrate technical expertise and leadership as an inter-departmental resource coaching and teaching other Integra team members across all functions and geographies.
• Perform other related duties as expected.

Qualifications:

• Experience with Corporate, divisional, site, supplier GMP, GDP, GLP or GCP (as applicable) audits as a Lead Auditor for multi-national manufacturing companies in the medical devices or pharmaceutical sector.
• Related quality/operations GMP work experience in a medical device or pharmaceutical manufacturing site or an equivalent combination of education and work experience in QS/QA/QC/OPS or a technical management and supervisory function.
• Experience auditing technical files for conformance with EU regulations for CE-marked medical devices.
• Experience working for regulatory agencies (such as U.S. FDA, MHRA, TGA, Health Canada, SFDA, ANVISA, US state, etc.) or Notified Bodies (such as BSI, NSAI, LRQA, TüV, etc.) preferred.
• Experience in one or more of these specialized technical areas: sterilization, microbiology, manufacturing facility engineering and design, statistical analysis, process validation, regulatory compliance, clinical trials, computer systems validation, quality systems and/or data security.
• A working knowledge of different languages and a willingness to travel widely, including internationally, (up to 50%) would also be considered as assets.
• Conducting supplier / regulatory compliance audits at medical device and/or pharmaceutical companies with a demonstrated ability to identify and resolve complex quality and compliance issues.
• Intimate knowledge of the 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, and MDSAP country requirements; personal experience in the roll-out and implementation of GMP, GDP, GCP, GLP, and ISO 14971 would be considered an asset.
• Participated in or personally led audits of materials suppliers, manufacturing sites, distribution centers, and/or laboratories as a Lead Auditor or site QA/RA representative.
• Bachelor’s degree in engineering, or sciences or relevant technical field required. Master’s degree preferred.
• Formal Auditor certification by a recognized body (e.g., IRCA, ASQ CQA, BSI, Exemplar Global).
• Minimum 15 years of experience in auditing in quality, manufacturing, or engineering, or equivalent education and years of experience.
• Experience in FDA controlled environment.
• Strong collaboration skills and experience working in a matrix environment.