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Integra LifeSciences · 1 day ago

Senior Quality Compliance Manager - Lead Auditor

Princeton, NJ

Full-time

Onsite

Senior Level, Lead/Staff

$125K/yr - $172K/yr

15+ years exp

Integra LifeSciences is a company focused on creating change in healthcare and advancing patient outcomes. The Senior Quality Compliance Manager will lead and perform corporate audits of the Quality Management System across various facilities, ensuring compliance with global policies and standards.

BiotechnologyHealth CareLife ScienceMedicalMedical Device

Hiring Manager

Patrick Rogers

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

Qualification

Lead Auditor experienceGMP auditingISO 13485 knowledgeRegulatory complianceTechnical file auditingFormal Auditor certificationQuality Management SystemCollaboration skillsInterpersonal skillsCommunication skills

Required

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