Project Quality Lead II

Company: Parexel International Corporation
Location: Glendale
Posted on: June 3, 2025

Job Description:

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Glendale, CAThe 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 initiativesKey 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 SMEsDocumentation & 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.
                • 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 equivalentEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: Parexel International Corporation, Prescott Valley , Project Quality Lead II, Other , Glendale, Arizona