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:

• 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).
• 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.