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Jobs at Parexel

Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. 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. We're not just the people with expertise, we're the people with heart.

Project Quality & Risk Lead II

Job ID 72410BR USA - Any Region - Home Based
Partner with operational delivery teams focusing on first-time quality, robust risk and issue management
and maintaining an inspection-ready state. Provide quality expertise through the execution of quality
SOPs to support operations, leadership and clients.

Qualifications

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 for assigned projects using the
available tools.

Facilitate identification, investigation and
remediation of quality issues as
assigned using available tools and
methodologies. Provide oversight,
transparency and tracking of quality
issues for assigned studies.

Assist with preparations, conduct and
response/action plan development for
audits/inspections as assigned.

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.

Develop and cultivate transparent quality
relationships, while managing
expectations with client quality
representatives, including when needed
fulfilling the roles of Portfolio/Client
Quality Lead.

Maintain compliance with Parexel
standards and mentor new PQRLs.

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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