Senior Quality Manager

ManagerManagerFull TimeRemoteSeniorTeam 501-1,000Since 2007H1B No SponsorCompany SiteLinkedIn

Location

Poland

Posted

9 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Quality Manager

TFS HealthScience - Contract Research Organization

• Provides functional and project-level quality oversight across assigned scope • Ensures compliance with GCP and other applicable GxP regulations • Supports and participates in eQMS lifecycle activities, including validation oversight activities, as required • Oversees and performs vendor quality management activities, including qualification, risk assessment, and RFIs; reviews and approves outputs generated by Quality Managers • Supports business units and clients on projects, including development and maintenance of project-specific quality frameworks and procedures • Generates, reviews and approves controlled documents; ensures consistency, regulatory compliance, and alignment with the QMS • Manages quality issues and CAPAs, including oversight of investigations, escalation of significant risks or delays, and decision-making on critical issues and suspected serious breaches • Participates in quality risk management activities, including risk identification, assessment, and review

Job Requirements

  • Bachelor's degree in Life Sciences (or equivalent experience)
  • 5+ years in quality management/QA
  • 5+ years in GxP auditing - nice to have
  • Strong expertise in GCP/GxP, QMS, and system validation
  • Proven ability to work independently and lead complex quality activities

Benefits

  • Competitive compensation package
  • Comprehensive benefits
  • Opportunity for personal and professional growth

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