Clinical Quality Operations Manager, Oncology

MSD

Clinical Quality Operations Manager responsible for operational quality activities in clinical trials. Ensuring compliance and quality management within therapeutic area operations.

Posted 5/20/2026full-timeRemote • New Jersey, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $142,400 - $224,100 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

accountable for the execution of operational quality activities within the assigned therapeutic area
oversee headquarters clinical quality operations and support clinical trial teams
embed quality into the Company's sponsored trials
ensure adequate vendor oversight and address quality issues
develop quality plans to implement quality by design within clinical development programs
maintain ongoing inspection readiness
prepare for, manage and follow up on regulatory inspections

Requirements

What you’ll need

Minimum of 6 years in clinical research
at least 2 years with developing and managing clinical quality systems and management of regulatory inspections
profound knowledge and comprehension of clinical development programs, clinical trial processes, quality management systems and quality control tools
expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
effective CAPA management solutions
experience with risk management tools and processes within the clinical quality framework
B.A./B.S. or M.A./M.S. Degree or equivalent in relevant health care area
further formal education in quality management or business management is preferred

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical researchclinical quality systemsregulatory inspectionsquality management systemsquality control toolsGCPICHCAPA managementrisk management toolsclinical development programs