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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Project Quality & Risk Lead I

Job ID 84840BR Glendale, California, United States of America

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.

Hybrid Role, Glendale, CA (Office & Home based)

As a Sr Project Quality & Risk Lead you will partner with operational delivery teams (Project Leads, Clinical Operational Leads & Site Management) focused on first-time quality, robust risk and issue management and maintain an inspection-ready state. You will serve as the SME (subject matter expert) and offer quality expertise through the execution of quality SOPs to support operations, leadership and clients. 

Skills

  • Analyze key risk indicators and investigate risk signals by performing, reporting and coordinating risk-based quality evaluations for assigned projects using dashboards, reports, metrics and other available tools
  • Facilitate and drive the risk management process using the available tools
  • Facilitate identification, investigation and remediation of quality issues using available tools and methodologies.
  • Provide oversight, transparency and tracking of quality issues 
  • Assist with preparations, conduct and response/action plan development for audits/inspections
  • Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter experts
  • Partner with project teams to achieve and maintain inspection-ready state including story board oversight.

Knowledge & Experience

  • 5+ years’ experience in early phase or late phase clinical research
  • Experience using root cause methodologies (5-whys, fishbone diagram, etc.)
  • Knowledge of ICH-GCP principles
  • English proficiency (written and oral)

Education

  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

EEO Disclaimer

Parexel 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.

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