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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Project Quality Lead II
Job ID R0000033743 Glendale, CaliforniaGlendale, 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.
- 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.
Education:
- Educated to the degree level (biological science, pharma or health related discipline) or relevant clinical/quality equivalent
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