Parexel

GCP Quality Governance Operations Lead

Parexel

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Works with the quality governance chairs and coordinators to lead and execute quality governance forums addressing quality concerns and risk adjudication and escalation.
  • Plans, drafts, reviews and delivers outputs from quality governance forums including escalations, decisions, annual reports and other documentation as well as coordinate, prioritize and sequence quality governance topics.
  • Directs GCP quality governance metrics and assessment of GCP quality governance effectiveness and efficiency. Collects and reports data to support assessment of compliance to process, trends, and common issues with a view towards overall impact and continuous improvement
  • Serves as liaison between GCP quality governance board members and teams providing clear communication and direction on goals and objectives for review completion.
  • Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training

Requirements

  • 5+years of related pharmaceutical and/or quality experience
  • A robust understanding of GCP regulatory requirements and the Quality Management System (QMS)
  • Excellent verbal and written communication skills; must be able to interact effectively with professionals at all levels and communicate recommendations with diplomacy and tact
  • Strong project management skills, with experience managing time sensitive projects
  • Bachelor’s Degree or equivalent experience a must
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GCP regulatory requirementsQuality Management System (QMS)quality governance metricsdata collection and reportingcompliance assessmentcontinuous improvement
Soft Skills
verbal communicationwritten communicationinterpersonal skillsproject managementdiplomacytact