Global GCP Quality Auditor — Remote/Hybrid

Amgen, Inc.; Uxbridge; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global biotechnology company seeks a GCP Quality Auditor to plan and conduct compliance audits of clinical trials. The role involves identifying compliance risks and supporting regulatory inspections while offering opportunities for career development within a diverse and inclusive team. Candidates should have a degree and extensive GCP auditing experience. Flexibility for remote work is available, with possible international travel up to 40%.

Benefits

Generous Total Rewards Plan

Opportunities to learn and grow

Supportive work environment

Qualifications

• Degree educated.
• Proven and extensive international auditing experience in GCP.
• Experience of data mining, manipulation and data analytics would be advantageous.
• Excellent written and verbal communication skills.

Responsibilities

• Plan, conduct and report routine and directed GCP compliance audits internationally.
• Serve as a lead auditor for complex GCP audits.
• Identify and communicate compliance risks to R&D Quality management.
• Host and/or play a role in regulatory authority inspections.
• Contribute to or lead R&D Quality process improvement initiatives.
• Author and contribute to the development of R&D Quality cross-functional controlled documents.

Skills

International auditing experience in GCP

Data mining and data analytics

Excellent communication skills

Education

Degree

Job description

A global biotechnology company seeks a GCP Quality Auditor to plan and conduct compliance audits of clinical trials. The role involves identifying compliance risks and supporting regulatory inspections while offering opportunities for career development within a diverse and inclusive team. Candidates should have a degree and extensive GCP auditing experience. Flexibility for remote work is available, with possible international travel up to 40%.