Thermo Fisher Scientific · 19 hours ago
Audit Manager - Quality Assurance (QA) Internal Audit
Morrisville, NC
Full-time
Onsite
Senior Level
5+ years expThermo Fisher Scientific is a leader in scientific services, and they are seeking an Audit Manager to lead internal audits and ensure compliance with global regulations. The role involves planning and overseeing audits, engaging with site leaders, and promoting a culture of quality and continuous improvement.
Research
Responsibilities
Create and uphold an Annual Internal Audit Plan centered on risk management for GxP domains (GMP, GLP, GCP, GDP, etc.) that aligns with corporate quality goals
Periodically adjust the plan based on emerging risks, compliance history, regulatory updates, and business priorities
Conduct audits in alignment with relevant standards (e.g., FDA, EMA, ICH, ISO)
Coordinate logistics for internal audits across manufacturing sites, R&D facilities, and third-party operations
Engage with site Quality Heads and operational leads to ensure audit readiness and collaboration
Prepare audit documentation, agendas, and communications in advance of each audit
Evaluate audit results and quality data to establish and sustain metrics for monitoring the health of the audit program, trends, and site performance
Prepare and present monthly and quarterly audit dashboards and reports to Quality leadership
Track and follow up on CAPAs and systemic issues to evaluate long-term quality improvement
Monitor regulatory agency updates, warning letters, and inspection trends to inform internal audit focus areas
Provide monthly regulatory intelligence summaries with actionable insights for continuous compliance improvement
Integrate global regulatory expectations into audit tools, templates, and planning
Identify and implement improvements in audit practices, tools, and methodologies
Offer training and mentorship to audit team members and cross-functional collaborators
Promote a culture of proactive quality, risk awareness, and open communication
Qualification
Required
Bachelor's degree or equivalent experience in a scientific or technical field (e.g., Life Sciences, Pharmacy, Engineering)
Minimum 5 years of QA auditing experience in a GxP-regulated industry (pharmaceuticals, biotech, medical devices)
Proficient knowledge of international quality and regulatory standards (such as FDA, EMA, ICH Q-series, ISO 13485)
Excellent understanding of internal audit processes and quality systems
Strong ability in analyzing data with excellent interpretation and reporting skills
Proficient in tools such as TrackWise, Veeva QMS, Excel, and data visualization platforms (e.g., Power BI)
Clear communication and ability to engage across all levels of the organization
Skilled at balancing audit objectivity with collaborative engagement
Preferred
Lead Auditor certification or equivalent experience
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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