Bilingual Supervisor – Non Clinical Operations
CCS
Clinical Quality Operations Manager – FSP
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Responsible 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
- Maintain ongoing inspection readiness and prepare for regulatory inspections
- Ensure comprehensive oversight of all activities delegated to third parties
Requirements
- Bachelor’s/ Master’s Degree or equivalent in relevant health care area
- Minimum of 6 years of relevant experience in clinical research
- At least 2 years of direct experience with developing and managing clinical quality systems
- Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
- Experience with delivering effective CAPA management solutions
- Experience with risk management tools and processes within the clinical quality framework
- Superior oral and written communication skills in an international environment
- Ability to manage and develop others, including formal performance management when required
Benefits
- Health insurance
- Flexible working arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical quality systemsCAPA managementrisk management toolsGCPICHregulatory health authority requirementsquality plansquality by designinspection readinessclinical development programs
Soft skills
oral communicationwritten communicationmanagementperformance managementleadership
Certifications
Bachelor’s DegreeMaster’s Degree
