Quality Lead, GCP Internal Auditing

Key Responsibilities Include:

Conducting GCP audits of Clinical Investigator sites, vendors, databases, clinical labs, and systems and processes

Secure the clinical team's commitment on action plans

Provide regulatory expertise and process optimization to customer divisions, clinical teams, and conducting field interaction to reinforce QA Programs

Conducting GCP audits of processes related to clinical and business operations, clinical safety and pharmacovigilance, clinical drug development and pre- and post-marketed drug usage worldwide

Identify opportunities for GCP and business process and internal/external controls to assure high quality standards for GCP systems/processes and clinical safety and pharmacovigilance compliance with policies and regulations

Developing audit reports, coordinating action plans and following up with auditees to assure timely completion of agreed upon actions

Actively contribute to the development of clinical research, safety and clinical quality and compliance systems and standards

Develop activities related to GCP audit program, GCP Training, Audit/Inspection Support, and collaborating with Global Patient Safety

Assess clinical and business systems and processes to provide Quality management with an evaluation of internal and external controls

Requirements Include:

Master's degree in a scientific or allied health field and 3+ years of GCP and Quality Systems auditing work

Bachelor's degree in a scientific or allied health field and 6+ years of GCP and Quality Systems Auditing work

3+ years of experience in a Quality Role

To find out more about Real Staffing please visit www.realstaffing.com