Senior GCP QA Auditor – Lead Audits & Compliance

thermofisher; USA; Remote; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GCP QA

Audit leadership

Regulatory knowledge

Risk assessment

Root-cause analysis

Communication

Project management

Ausbildung

Bachelor's degree

Jobbeschreibung

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.