Clinical Quality Operations Manager
MSD
full-time
Posted on:
Location Type: Remote
Location: Remote • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $139,600 - $219,700 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- accountable for the execution of operational quality activities within the assigned therapeutic area
- oversee headquarters clinical quality operations and support clinical trial teams
- develop quality plans to implement quality by design within clinical development programs
- accountable for maintaining ongoing inspection readiness and preparing for regulatory inspections
- facilitate and oversee the responses to audit and inspection observations
- contribute to the standardization of Clinical Quality Operations procedures and templates
- develop the inspection management plan for each assigned Regulatory Health Authority inspection.
Requirements
- 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 as well as quality management systems and quality control tools
- Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
- Has delivered effective CAPA management solutions
- Has worked with risk management tools and processes within the clinical quality framework.
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical quality systemsquality management systemsquality control toolsCAPA managementrisk management toolsclinical development programsclinical trial processesinspection management planregulatory inspectionsaudit responses
Soft skills
accountabilityoversightfacilitationstandardizationcommunication