Project Quality & Risk Lead II
Parexel
Date: 12 hours ago
City: Glendale, CA
Contract type: Full time
Glendale, CA (Hybrid role - office & remote based)
The Project Quality & Risk Lead II is responsible for leading quality and risk oversight for clinical trials within the Early Phase Clinical Units. This role ensures first-time quality, robust risk and issue management and inspection readiness by collaborating with operational teams and clients. Key duties include facilitating risk assessments, managing quality events, supporting audits and inspections, and providing expert guidance on regulatory compliance. The position requires strong analytical, communication, and problem-solving skills, along with experience in clinical research, quality management, and ICH-GCP standards. It also involves mentoring new team members and contributing to continuous improvement initiatives
Key Responsibilities
Client Liaison & Communication
The Project Quality & Risk Lead II is responsible for leading quality and risk oversight for clinical trials within the Early Phase Clinical Units. This role ensures first-time quality, robust risk and issue management and inspection readiness by collaborating with operational teams and clients. Key duties include facilitating risk assessments, managing quality events, supporting audits and inspections, and providing expert guidance on regulatory compliance. The position requires strong analytical, communication, and problem-solving skills, along with experience in clinical research, quality management, and ICH-GCP standards. It also involves mentoring new team members and contributing to continuous improvement initiatives
Key Responsibilities
Client Liaison & Communication
- Act as the main contact for client quality representatives.
- Respond to urgent quality requests and facilitate quality-to-quality meetings.
- Lead risk identification and mitigation processes.
- Develop and assess risk mitigation strategies and quality tolerance limits.
- Triage and classify quality issues.
- Facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA).
- Conduct Inspection Readiness Checks (IRCs).
- Support audit/inspection preparation and response.
- Provide real-time quality advice.
- Review SOP deviations and consult with SMEs
- Ensure inspection-ready documentation.
- Oversee storyboard development and updates.
- Identify and propose process improvements.
- Participate in quality system enhancements.
- Mentor and train new PQRLs.
- Strong communication and interpersonal skills.
- GCP experience highly preferred
- Critical thinking and analytical abilities.
- Experience with root cause analysis tools (e.g., 5 Whys, Fishbone).
- Ability to manage workload independently and in a matrix environment.
- Educated to the degree level (biological science, pharma or health related discipline) or relevant clinical/quality equivalent
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