Job Description

Quality Manager I

12-month Contract

Remote- EST Hours

Requirements

• 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.

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