Parexel

GCP Quality Governance Operations Lead – Senior Manager

Parexel

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

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.
  • Execution and oversight of the periodic review of GCP quality governance forum remit, charter, scope, membership.
  • Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training.

Requirements

  • Have a robust understanding of GCP regulatory requirements and the Quality Management System (QMS).
  • Will be able to engage directly with various business representatives, business process owners, and leadership teams to assist with the adoption of consistent data privacy practices.
  • Will require pharmaceutical industry acumen.
  • Will be an effective communicator, demonstrate domain competency with respect to data privacy, and be familiar with operationalizing global or regional processes.
  • Will demonstrate strong analytical and critical thinking abilities, with a track record of identifying and resolving issues effectively.
  • Bachelor’s Degree or equivalent experience a must
  • 5+ years of related pharmaceutical and/or quality experience.
Benefits
  • 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.
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)data analysiscompliance assessmentquality governance metricsrisk adjudicationcontinuous improvementdocumentation draftingdata reportingissue resolution
Soft Skills
effective communicationanalytical thinkingcritical thinkingcollaborationleadershiporganizational skillsproblem-solvingstakeholder engagementdirection providinggoal orientation