Quality Manager Jobs

About The Position

Requirements

• BS/BA Degree in a scientific discipline.
• 8+ years experience in a related industry.
• 6+ years experience in a Clinical Quality Assurance role, including experience with external and internal audits.
• Demonstrated experience working with clinical trial teams.
• Extensive experience with Global Clinical trial conduct, knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements.
• Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.

Nice To Haves

• Advanced degree preferred.
• Previous experience in supporting Regulatory Authority Inspections preferred.
• Previous experience in development and oversight of Quality Management Systems.

Responsibilities

• Provide proactive GCP QA support and guidance to Clinical Trial Teams, leveraging analysis and interpretation of GCP regulations to ensure best practices in Clinical and QA operations.
• Lead integration of acquired clinical programs into existing quality frameworks, ensuring seamless transition of processes, systems, and compliance standards following mergers, acquisitions or partnerships.
• Partner with teams to resolve compliance issues identified at clinical vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions.
• Assist in the development and implementation of CAPA plans and investigations in response to quality issues, audits, and inspections.
• Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements.
• Develop and maintain study-specific audit plans for assigned studies; support audit preparation, site selection, and execution, including coordination of responses.
• Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies.
• Support inspection readiness activities for sponsors, monitors, and sites; provide guidance and hands-on support during all GxP inspection activities.
• Coordinate and manage external audit consultants as needed to ensure quality and consistency.
• Perform other related duties and special projects as assigned.

Benefits

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers