TFS HealthScience is a leading global mid-size Contract Research Organization that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. We are currently seeking a Senior Quality Manager to join our dedicated quality team and ensure excellence across our global operations.
Key responsibilities
- Provide functional and project-level quality oversight to ensure full compliance with GCP and applicable GxP regulations.
- Oversee vendor quality management activities, including qualification, risk assessment, and the review of quality outputs.
- Manage quality issues and CAPAs, including the oversight of investigations and the escalation of significant risks.
- Support business units and clients by developing and maintaining project-specific quality frameworks and procedures.
- Independently conduct GCP/GxP audits of vendors, systems, and clinical trials to maintain high standards.
Requirements
- Bachelor’s degree in Life Sciences or equivalent professional experience.
- At least 5 years of experience in quality management or quality assurance roles.
- Strong expertise in GCP/GxP, Quality Management Systems, and system validation processes.
- Proven ability to work independently and lead complex quality-related activities within a global environment.
What we offer
- A competitive compensation package and comprehensive benefits tailored to support your well-being.
- Opportunities for continuous personal and professional growth within a rewarding, innovative environment.
- The chance to join a collaborative team dedicated to making a meaningful difference in the lives of patients worldwide.