Audit Manager Quality Assurance (QA) Internal Audit

Audit Manager

Lead internal audits at Thermo Fisher Scientific as an Audit Manager. Ensure compliance with global regulations.

Key Responsibilities

• 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 (e.g., 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

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.