Senior GxP Auditor & Quality Compliance SME

RxCloud; Roma; On-site; EUR 110,000 - 170,000; Full time

Job summary

RxCloud in Rome seeks an experienced GxP Auditor to join the Quality and Compliance team. You will plan and conduct scheduled quality audits for external CDMOs, clinical sites, and internal labs, acting as a SME for GxP auditing and quality projects.

You will independently manage auditing deliverables, develop the global audit strategy, and participate in continuous improvement of the Quality Management Auditing system. Strong regulatory knowledge and cross-functional collaboration are essential.

Qualifications

• Bachelor's degree in a scientific discipline.
• 20+ years of relevant experience with at least 15 years in GxP auditing in a regulated environment.
• Excellent knowledge of GxP regulatory requirements.
• Experience using electronic Quality Management Systems.
• Ability to manage multiple projects in a fast-paced environment.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Detail oriented; precise and organized in document handling.

Responsibilities

• Plan and conduct scheduled quality audits for external CDMOs, clinical sites, and internal labs.
• Develop and implement the global audit strategy in line with regulatory requirements.
• Perform audits across departments and functional areas.
• Conduct risk assessments and develop audit plans and procedures.
• Review internal controls and recommend improvements to mitigate risks.
• Collaborate with finance, operations, compliance, and legal to address audit findings.
• Lead investigations into fraud or non-compliance and propose appropriate actions.
• Prepare comprehensive audit reports with findings and action plans.

Skills

GxP auditing

Quality management

Cross-functional collaboration

Education

Bachelor's degree

Job description

RxCloud in Rome seeks an experienced GxP Auditor to join the Quality and Compliance team. You will plan and conduct scheduled quality audits for external CDMOs, clinical sites, and internal labs, acting as a SME for GxP auditing and quality projects.

You will independently manage auditing deliverables, develop the global audit strategy, and participate in continuous improvement of the Quality Management Auditing system. Strong regulatory knowledge and cross-functional collaboration are essential.