Job Title: Quality Manager
Location: Remote
Job Summary: We are recruiting for an opportunity supporting clinical quality activities with a strong focus on audit coordination, inspection readiness, and CAPA management. This position plays an important part in helping maintain quality system processes and supporting cross-functional teams across clinical development activities.
Responsibilities:
- Support coordination and execution of the GCP audit program, including investigator site, vendor, and internal process audits.
- Assist with audit preparation meetings, documentation, audit packages, reports, and follow-up actions.
- Maintain quality records, track CAPAs, and support continuous improvement within clinical quality systems.
- Contribute to regulatory inspection readiness activities, meeting coordination, reporting, and quality metrics support.
Required:
- Bachelor’s degree in Life Sciences or a related scientific discipline preferred.
- Minimum 5 years of relevant experience in pharmaceutical, biotechnology, or clinical research environments.
- Exposure to clinical trial operations, quality assurance, monitoring activities, quality systems, CAPA management, or inspection readiness activities.
- Foundational knowledge of Good Clinical Practice (ICH E6), applicable regulations, and clinical development processes.
- Candidates need genuine hands-on experience in:
- GCP / Clinical Quality
- Clinical drug development environment
- Audit management/support
- Inspection readiness/support
- CAPA and corrective action plans
- Root Cause Analysis
- Risk assessment
- Audit findings and responses
- Cross-functional stakeholder coordination