Senior Quality Compliance Manager Lead Auditor

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SUMMARY

The Senior Quality Compliance Manager will lead coordinate and perform corporate audits of the Quality Management System (QMS) as part of Integra LifeSciences 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 programs targets on-time and to-budget.

ESSENTIAL DUTIES AND 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 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.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge skill and experience required for this position.

• 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.

• Bachelors degree in engineering or sciences or relevant technical field required. Masters 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.

Salary Pay Range:

Our salary ranges are determined by role level and location. Individual pay is determined by several factors including job-related skills experience and relevant education or training. In addition to base pay employees may be eligible for bonus commission equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire Employees are eligible for the following LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.

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