GCP Quality & Audit Operations Lead

Real; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Real is seeking an experienced professional to support GCP audit programs and regulatory inspections. The role focuses on coordinating audits, maintaining schedules, and ensuring quality system documentation.

You will work with Global Quality leadership and cross-functional teams to drive audit readiness, CAPA follow-ups, and continuous improvement of the Clinical Quality Management System. Strong communication and organizational skills are essential.

Qualifications

• Bachelor's degree in Life Sciences or related scientific discipline preferred.
• Min 5 years of relevant experience in pharmaceutical, biotechnology, or clinical research environments, ideally with Clinical Quality background (GCP, not GMP).
• Exposure to clinical trial operations, quality assurance, or monitoring activities preferred.
• Basic understanding of GCP and clinical development processes.
• Exposure to quality systems, CAPA management, or inspection readiness activities desirable.
• Foundational knowledge of Good Clinical Practice (ICH E6) and applicable regulations.

Responsibilities

• Coordinate and execute the GCP audit program, including investigator site, vendor, and internal process audits.
• Assist with maintaining and tracking the Master Audit Schedule.
• Coordinate audit preparation meetings with cross-functional teams and external auditors.
• Support preparation of audit documentation and audit packages.
• Assist in the preparation and review of audit reports and supporting documentation.
• Track and follow up on CAPAs resulting from audits.
• Support maintenance and continuous improvement of the Clinical Quality Management System (QMS).
• Maintain audit documentation and quality records within electronic quality systems (TrackWise, Veeva, ACE).
• Collaborate with Clinical Operations, Data Management, Pharmacovigilance, and other functions during audit activities.

Skills

GCP knowledge

Audit coordination

Cross-functional collaboration

Documentation management

Attention to detail

Education

Bachelor's degree in Life Sciences

Tools

TrackWise

Veeva

ACE

Job description

Real is seeking an experienced professional to support GCP audit programs and regulatory inspections. The role focuses on coordinating audits, maintaining schedules, and ensuring quality system documentation.

You will work with Global Quality leadership and cross-functional teams to drive audit readiness, CAPA follow-ups, and continuous improvement of the Clinical Quality Management System. Strong communication and organizational skills are essential.