Audit Manager – Quality Assurance (QA) Internal Audit

Work Schedule

Environmental Conditions

Job Description

Position Overview

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

Education & Experience:

• Bachelors 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).
• 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 (e.g. Power BI).
• Clear communication and ability to engage across all levels of the organization.
• Skilled at balancing audit objectivity with collaborative engagement.