Overview
Project Quality Lead II Jobs in Glendale, California, USA at Parexel
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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
Act as the main contact for client quality representatives.
Respond to urgent quality requests and facilitate quality-to-quality meetings.
Risk Management
Lead risk identification and mitigation processes.
Develop and assess risk mitigation strategies and quality tolerance limits.
Quality Event Management
Triage and classify quality issues.
Facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA).
Inspection Readiness
Conduct Inspection Readiness Checks (IRCs).
Support audit/inspection preparation and response.
Quality Consultancy
Provide real-time quality advice.
Review SOP deviations and consult with SMEs
Documentation & Storyboards
Ensure inspection-ready documentation.
Oversee storyboard development and updates.
Continuous Improvement
Identify and propose process improvements.
Participate in quality system enhancements.
Mentorship
Mentor and train new PQRLs.
Skills Required
Strong communication and interpersonal skills.
Critical thinking and analytical abilities.
GCP experience highly preferred
Experience with root cause analysis tools (e.g., 5 Whys, Fishbone).
Ability to manage workload independently and in a matrix environment.
Education
Educated to the degree level (biological science, pharma or health related discipline) or relevant clinical/quality equivalent
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance, Research, and Product Management
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care
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Title: Project Quality Lead II
Company: Parexel
Location: Glendale, California, USA
Category: Quality Assurance – QA/QC (Quality Engineering)
