Quality Manager II

Quality Manager II
6-month contract
Remote – EST hours
Must be able to work on a W2

Position Summary
Our client is seeking a Quality Manager II to 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. This role will provide operational support for the GCP audit program, regulatory inspection readiness, CAPA management, and clinical quality system processes. The Quality Manager II will work closely with Global Quality leadership and cross-functional teams to coordinate audit and inspection activities, maintain quality documentation, track CAPAs and commitments, and support continuous improvement of the Clinical Quality Management System (QMS).

Key Responsibilities

GCP Audit Program

• Support the coordination and execution of GCP audits, including investigator site, vendor, and internal process audits.
• Maintain and track the Master Audit Schedule.
• Coordinate audit preparation meetings with cross-functional teams and external auditors.
• Support preparation of audit documentation, audit packages, and supporting materials.
• Assist with preparation and review of audit reports.
• Track and follow up on CAPAs resulting from audits.
• Maintain accurate audit documentation and quality records.

• Support the maintenance and continuous improvement of the Clinical Quality Management System.
• Maintain audit documentation and quality records within electronic quality systems such as TrackWise, Veeva, or ACE.
• Assist with tracking quality issues, CAPAs, and commitments related to clinical programs.
• Partner with Clinical Operations, Data Management, Pharmacovigilance, and other functions on quality activities.
• Identify opportunities for process improvements within clinical development activities.

• Support preparation for regulatory inspections, including FDA, EMA, and PMDA inspections.
• Assist clinical study teams with inspection readiness activities.
• Organize and maintain inspection-related documentation.
• Track and follow up on inspection-related CAPAs and commitments.

• Provide operational and project coordination support for clinical quality initiatives.
• Coordinate cross-functional meetings related to audits and inspection readiness.
• Prepare meeting agendas, minutes, and action trackers.
• Track project milestones and follow up on outstanding activities.
• Support preparation of quality metrics, dashboards, and management reports.

• Bachelor’s degree in Life Sciences or a related scientific discipline preferred.
• 5+ years of relevant experience within pharmaceutical, biotechnology, or clinical research environments.
• Clinical Quality or GCP-focused experience required; this is not a GMP-focused role.
• Exposure to clinical trial operations, Quality Assurance, or clinical monitoring activities preferred.
• Foundational knowledge of GCP, ICH E6, and applicable clinical research regulations.
• Understanding of clinical trial processes and sponsor oversight responsibilities.
• Experience or exposure to GCP audits, CAPA management, quality systems, or regulatory inspection readiness preferred.
• Pharmacovigilance/GVP experience or background is a plus.
• Familiarity with electronic quality systems such as TrackWise, Veeva, or ACE preferred.
• Experience with audit tracking and quality documentation systems is desirable.