GCP QA Auditor III

thermofisher; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Thermo Fisher Scientific seeks a Lead Quality Assurance Auditor to drive GCP audits across client and vendor programs, ensuring compliance with regulatory requirements and quality procedures.

You will plan and lead audits, provide GCP guidance to project teams, and mentor junior auditors in a varied environment that may include office, lab, or clinical settings.

The role requires five or more years of GCP QA experience, strong communication, risk assessment, and the ability to travel as needed.

Qualifications

• Bachelor's degree or equivalent with relevant qualifications.
• Around five or more years of GCP QA experience.
• Detailed knowledge of GCP and regional regulations.
• Experience leading audits (GCP, vendor, internal).
• Strong written and verbal communication, risk assessment, root-cause investigation skills.
• Negotiation and conflict-management ability; travel readiness.

Responsibilities

• Plan and lead client, internal, GCP, site, facility, vendor, and subcontractor audits; regulatory inspections.
• Provide GCP advice and quality support to project teams and external clients.
• Lead process audits and co-audit complex system audits.
• Conduct other quality reviews, such as database or clinical study report audits, sample-results reviews, and process improvement work.
• Analyze findings, risks, impacts, and root causes; prepare and present audit reports and recommendations.
• Act as a quality resource for operational teams and mentor junior auditors.

Skills

GCP QA

Audit leadership

Regulatory knowledge

Risk assessment

Root-cause analysis

Communication

Project management

Education

Bachelor's degree

Job description

Role overview

Lead quality assurance audits and related reviews to assess compliance with Good Clinical Practice (GCP), applicable regulations, quality procedures, and contractual requirements. The role covers internal and external audits, vendor and site assessments, and consultation for project teams and clients. It also identifies quality risks, investigates non-conformances, and supports improvements across operational processes.

Responsibilities

• Plan and lead client, internal, GCP, site, facility, vendor, and subcontractor audits, as well as requested regulatory inspections.
• Provide GCP advice and quality support to project teams and external clients.
• Lead process audits and contribute to more complex system audits as a co-auditor.
• Conduct other quality reviews, such as database or clinical study report audits, sample-results reviews, and process improvement work.
• Analyze findings, risks, impacts, and root causes; prepare and present audit reports and recommendations.
• Act as a quality resource for operational teams and mentor junior auditors.

Requirements

• Bachelor's degree or equivalent, with relevant academic or vocational qualifications.
• Around five or more years of relevant GCP quality assurance experience, or an equivalent combination of education, training, and directly related experience.
• Detailed knowledge of GCP and relevant regional research regulations and guidelines.
• Experience leading project-based or internal GCP audits and vendor audits to a high standard.
• Strong written and verbal communication, problem-solving, risk assessment, impact analysis, and root-cause investigation skills.
• Negotiation and conflict-management ability, flexibility to manage competing work, and a valid driver's license; able to qualify for and maintain a corporate credit card for business travel.

Benefits and work setup

Work may take place in an office, laboratory, or clinical setting. Some assignments involve exposure to biological fluids or potentially infectious organisms, and protective eyewear, garments, and gloves may be required.