Audit Manager – Quality Assurance (QA) Internal Audit at Thermo Fisher Scientific

Morrisville, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life SciencesIndustries

Requirements

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
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

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

Skills

Key technologies and capabilities for this role

Internal AuditGMPGLPGCPGDPFDAEMAICHISORisk ManagementCAPARegulatory ComplianceAudit PlanningQuality MetricsContinuous Improvement

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Audit Manager role?

A Bachelor’s degree or equivalent in a scientific or technical field like Life Sciences, Pharmacy, or Engineering is required, along with a minimum of 5 years of QA auditing experience in a GxP-regulated industry. Proficient knowledge of international standards such as FDA, EMA, ICH Q-series, and ISO 13485 is needed, with Lead Auditor certification preferred.

What key skills are needed for this position?

Candidates need excellent understanding of internal audit processes and quality systems, strong data analysis and reporting skills, proficiency in tools like TrackWise, Veeva QMS, Excel, and Power BI, clear communication across all levels, and the ability to balance audit objectivity with collaboration.

Is this a remote position, or does it require office work?

The role is based in an office environment with a standard Monday-Friday work schedule.

What is the salary or compensation for this Audit Manager position?

This information is not specified in the job description.

What does the company emphasize about its quality culture?

The role promotes a culture of proactive quality, risk awareness, and open communication through continuous improvement in audit practices and training for team members and collaborators.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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