Support the Global Quality Management team in ensuring compliance with Good Clinical Practice (GCP), applicable regulatory requirements, and internal quality standards across clinical development activities.
Provide operational support of the GCP audit program, clinical inspection readiness activities, CAPA management, and quality system processes.
Coordinate and maintain audit and inspection activities in collaboration with Global Quality leadership and cross-functional stakeholders.
Support coordination and execution of 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 Corrective and Preventive Actions (CAPAs) resulting from audits.
Maintain documentation and records related to audit activities.
Support maintenance and continuous improvement of the Clinical Quality Management System (QMS).
Maintain audit documentation and quality records within electronic quality systems (e.g., TrackWise, Veeva, ACE).
Assist with tracking quality issues, CAPAs, and commitments related to clinical programs.
Collaborate with Clinical Operations, Data Management, Pharmacovigilance, and other functional areas during audit and quality activities.
Assist with identification of quality process improvements within clinical development processes.
Support preparation activities for regulatory inspections (e.g., FDA, EMA, PMDA).
Assist in coordinating inspection readiness activities across clinical study teams.
Support preparation and organization of inspection documentation.
Assist with tracking and follow-up of inspection-related CAPAs and commitments.
Provide operational and project coordination support for clinical quality initiatives.
Assist in organizing cross-functional meetings related to audit and inspection readiness.
Prepare meeting agendas, minutes, and action trackers.
Track project milestones and support follow-up activities.
Support preparation of quality metrics, dashboards, and management reports.
Qualifications
Bachelor’s degree in Life Sciences or related scientific discipline preferred.
Minimum 3 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.
Understanding of clinical trial processes and sponsor oversight responsibilities.
Strong organizational and coordination skills.
Attention to detail and ability to manage multiple priorities.
Strong written and verbal communication skills.
Ability to work collaboratively in a cross-functional environment.
Analytical thinking and problem-solving skills.
Ability to apply a risk-based approach to quality activities.
Proficiency with Microsoft Office (Excel, PowerPoint, Word).
Familiarity with quality management systems such as TrackWise, Veeva, or ACE preferred.
Experience with audit tracking tools and documentation systems is desirable.
