Manager, Compliance Quality Assurance

Indivior

Raleigh, NC, United States
Quality systems management
Document control
Regulatory compliance
The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA team, including site Quality events, Compliance, Document Control, APQR, Quality Technical Agreements, self-inspections, and Bulk Product dispositions

Job Summary

  • The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA team, including site Quality events, Compliance, Document Control, APQR, Quality Technical Agreements, self-inspections, and Bulk Product dispositions.
  • Essential functions include supervising, developing, managing, and training direct reports, managing the APQR process, overseeing the Document Management System, and ensuring the site maintains a constant state of inspection readiness.
  • Indivior offers a culture driven by guiding principles and top-tier benefits, including vacation, 401(k) with company match, stock purchase plan, comprehensive health coverage, and tuition reimbursement.

Matching Summary

The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA team, including site Quality events, Compliance, Document Control, APQR, Quality Technical Agreements, self-inspections, and Bulk Product dispositions.

Skills & Requirements

Must-have

  • Quality Systems Management
  • Document Control
  • Regulatory Compliance
  • Root Cause Analysis
  • Risk Assessment
  • Inspection Readiness

Nice-to-have

  • Continuous Improvement Culture
  • Entrepreneurial and Self-Motivated
  • Strategic Thinking
  • Data Analysis and Interpretation

Key Requirements

  • Bachelor of Science degree in a relevant scientific field
  • Minimum ten (10) years of experience in pharmaceutical manufacturing
  • Minimum five (5) years of progressive supervisory experience
  • Prior Quality System Management experience
  • Experience in a sterile manufacturing environment

Work Rights

Not specified

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