Global GCP Audit Lead

BioSpace; Washington (District of Columbia); Sur place; USD 130 000 - 180 000; Plein temps

Avantages offerts par ce poste

Health and welfare plans

Retirement and Savings Plan

Stock-based incentives

Flexible work models

Résumé du poste

Amgen seeks a GCP Auditor to join its Global R&D Audit team, conducting routine and lead audits across an international remit. The role supports R&D Quality and interfaces with regulatory inspections to ensure GCP compliance during development and post-marketing phases.

The candidate will drive risk identification, process improvements, and cross-functional documentation development, with up to 40% travel internationally.

Qualifications

• GCP auditing experience or regulatory inspections experience.
• Strong ability to communicate risks to management.
• Experience conducting audits across global settings.

Responsabilités

• Plan, conduct and report routine and direct 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 participate in regulatory authority inspections.
• Contribute to or lead R&D Quality process improvement initiatives.
• Author and contribute to R&D Quality controlled documents.

Connaissances

GCP auditing

Regulatory inspections

Cross-functional collaboration

Formation

Doctorate degree

Masters degree in science

Bachelors degree in science

High school diploma / GED

Description du poste

Amgen seeks a GCP Auditor to join its Global R&D Audit team, conducting routine and lead audits across an international remit. The role supports R&D Quality and interfaces with regulatory inspections to ensure GCP compliance during development and post-marketing phases.

The candidate will drive risk identification, process improvements, and cross-functional documentation development, with up to 40% travel internationally.