Lead Auditor, Compliance

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?


The Lead Auditor, Compliance is responsible for conducting in-depth audits of Thermo Fisher Scientific regulated and non-regulated sites to ensure compliance with government regulations and applicable standards, as well as compliance with company policy and procedures. Audits will follow FDA and ISO Notified Body style and approach to ensure identification of risks that will be then be reported to site management for remediation. The incumbent will also provide supplemental internal auditor training to site personnel. The Lead Auditor, Compliance is part of a broader Corporate Audit Team responsible for driving an independent, thorough and collaborative process that advances Thermo Fisher Scientific’s compliance standing.

What will you do?

• Conduct FDA and Notified Body style audits enterprise-wide at regulated and non-regulated sites to verify compliance with government regulations and applicable standards along with Thermo Fisher Scientific policies and procedures.
• Assure Quality System Audits comply with FDA QSR/GMP, ISO and applicable international requirements.
• Provide guidance regarding compliance with applicable standards and regulations.
• Conduct re-audits as necessary to address identified compliance gaps and to follow up on corrective/preventive actions as necessary and appropriate.
• Assign classifications to internal audit observations and document audit results in written reports that are distributed and reviewed by the appropriate management.
• Review appropriateness of responses to audit observations.
• Monitor the effectiveness of the corrective actions documented on the observation responses.
• Maintain audit report files, re-audit files and the responses to the audits performed.
• Assist with the development of Policies and Regulatory Procedures in compliance with standards and applicable local, state and federal regulations.
• Stay abreast of government regulations and applicable standards changes through continuous education (publications, seminars, peer/industry networking).
• Communicate business-related issues/opportunities to next management level.
• Ensure personal and company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Analyze quality data such as CAPAs, complaints, audit reports and other relevant data to identify and report systemic quality systems issues.

• Bachelor of Science Degree in Science, Technology, Engineering or Math disciplines
• Former FDA investigators required with a minimum of 3-5 years FDA field auditing experience.
• 5 years Life Science industry experience required.
• 5 years practical experience operating within certified quality systems required.
• 35 to 50% travel is required
• Knowledge of FDA GxP, 21 CFR Part 820, 806, 803, 210, 211, ISO 13485, ISO 9001 and global regulatory standards required.
• Software auditing experience preferred.
• Current knowledge of computer operating systems required
• Must be familiar with compliance IT systems such as TrackWise or MasterControl.
• Experience with methods and techniques related to quality, including auditing principles and techniques, quality terminology, quality administration principles and their applications, along with the quality administration tools and their applications are required.
• Analytical skills to interpret scientific and technical publications and legal documents is required.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.