Audit Manager – Quality Assurance (QA) Internal AuditThermo Fisher Scientific • Morrisville, North Carolina, United States of America

Audit Manager – Quality Assurance (QA) Internal Audit

Thermo Fisher Scientific • Morrisville, North Carolina, United States of America

19 days ago

Job type

Full-time

Job description

Internal Audit Planning & Oversight

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 (, FDA, EMA, ICH, ISO).

Site Engagement & Audit Logistics

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.

Metrics Development & Data-Driven Reporting

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.

Regulatory Intelligence & Trend Identification

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.

Continuous Improvement & Quality Culture

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.

Qualifications

Education & Experience :

Bachelor’s degree or equivalent experience in a scientific or technical field (, 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).

Lead Auditor certification or equivalent experience preferred.

Skills & Proficiencies :

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 (, Power BI).

Clear communication and ability to engage across all levels of the organization.

Skilled at balancing audit objectivity with collaborative engagement.

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Quality Assurance Manager • Morrisville, North Carolina, United States of America

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