Senior Clinical Quality Assurance Associate
New
W
WEP ClinicalPharmaceutical
Remote, USFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 3 to 5 years
- Required Skills
- GCPQuality Assurance
Requirements
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration).
- 3 to 5 years of experience in a quality-related role within a CRO, pharmaceutical, biotechnology, or healthcare organization.
- Experience supporting global clinical trials and decentralized clinical trial activities.
- Experience supporting Sponsor audits, regulatory inspections, internal audits, and/or supplier audits.
- Practical experience with quality investigations, CAPAs, root cause analysis, quality risk assessments, and continuous improvement.
- Experience with eQMS, eTMF, Microsoft Office, and quality management software applications.
- Working knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, and GDPR.
- Strong understanding of Quality Management Systems and risk-based quality management principles.
- Understanding of computerized system validation or validation lifecycle principles.
- Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes is advantageous.
Responsibilities
- Serve as GCP quality systems SME across global clinical operations.
- Provide QA oversight to operational teams including Clinical Operations, Nursing, and Medical Affairs.
- Lead investigations for non-conformances, protocol deviations, and compliance issues.
- Independently manage complex CAPAs from investigation through closure.
- Lead risk assessments for new processes, vendors, and systems.
- Review clinical and GCP documentation including protocols, ICFs, and eCRFs.
- Oversee decentralized clinical trial activities and nursing/home healthcare processes.
- Support vendor qualification, audits, and performance monitoring.
- Manage audit and inspection readiness, documentation, and response plans.
- Review quality metrics to identify trends and drive continuous improvements.
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