Quality Manager, GCP

Key Responsibilities

• GCP Audit Program Support
• Support coordination and execution of the GCP audit program, including investigator site, vendor, and internal process audits.
• Audit preparation meetings with cross-functional teams and external auditors.
• Support preparation of audit documentation and audit packages.
• Audit report preparation and review.
• Corrective and Preventive Actions (CAPA) management.
• Documentation and record maintenance related to audit activities.
• Clinical Quality System Support
• Maintain and improve the Clinical Quality Management System (QMS).
• Quality records and documentation in electronic systems (e.g., TrackWise, Veeva, ACE).
• Track and manage quality issues, CAPAs, and commitments.
• Collaboration with various functional areas during audits and quality activities.
• Identify and implement process improvements within clinical development processes.
• Regulatory Inspection Readiness
• Inspection preparation activities (e.g., FDA, EMA, PMDA).
• Coordination of inspection readiness activities across clinical study teams.
• Preparation and organization of inspection documentation.
• Tracking and follow-up on inspection-related CAPAs and commitments.
• Quality Program Coordination
• Operational and project coordination support for clinical quality initiatives.
• Organize 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 & Experience

• Education: Bachelor's degree in Life Sciences or related scientific discipline preferred.
• Experience: Minimum 5 years of relevant experience in pharmaceutical, biotechnology, or clinical research environments, preferably with a Clinical Quality background (GCP, not GMP).
• Functional Experience: Exposure to clinical trial operations, quality assurance, or monitoring activities.
• Knowledge: Basic understanding of GCP and clinical development processes, exposure to quality systems, CAPA management, or inspection readiness activities, 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, 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, experience with audit tracking tools and documentation systems, and Pharmacovigilance, GVP experience/background preferred.