Description
We are seeking a CAPA Management Lead to join our team. As a CAPA Management Lead, you will lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses.
Key Responsibilities:
- Lead and mentor members of the CAPA management team, with a focus on driving improvement and compliance
- Lead and support CAPA activities for complex QIs and sponsor audits and inspections
- Collaborate with cross-functional stakeholders to identify process gaps and areas of improvement
- Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS)
- Promote a culture of proactive and continuous process improvement
- Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff
- Develop and/or provide training and guidance on Root Cause Analysis (RCA), CAPA management, execution, good documentation practices, and compliance adherence
- Develop and/or improve governing procedures, templates, and work instructions
- Advise Quality Assurance management on system audit needs
- Support external and internal audits and inspections
Requirements:
- Extensive and demonstrable experience in GCP Quality Assurance within clinical trials
- Prior audit and inspection management/support experience within a GCP-regulated clinical trials environment
- Hands-on experience conducting root cause analyses and quality investigations related to clinical trial activities
- Proven experience reviewing, authoring, managing, and driving CAPAs to closure within a GCP clinical research environment
- Strong understanding of the end-to-end clinical trial lifecycle
- Demonstrated experience managing complex quality and compliance issues
- Bachelor's Degree in a Life Sciences, Healthcare, Pharmacy, Nursing, or related scientific discipline
- Excellent problem-solving, risk assessment, and root cause analysis skills
- Proven ability to train, mentor, and advise stakeholders on GCP quality and compliance requirements