Senior Quality Compliance Manager - Lead Auditor

Integra LifeSciences•Princeton, FL

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. SUMMARY The Senior Quality Compliance Manager 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. This role has responsibility to ensure that the corporate audit policy/procedures are fully implemented on audits conducted for which they are 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. The principal function is to lead, coordinate, physically perform and be responsible for the audits assigned to them 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. This role as a Subject Matter Expert (SME), will provide internal consultancy on area(s) of expertise to the audit team 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. Their 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.

Requirements

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.
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.
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.

Nice To Haves

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.
Master’s degree preferred.

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, Operations, 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 aforementioned 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.
Continues 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.
Demonstrates 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.