Manager of Product Quality Assurance

2 weeks ago


Raleigh, North Carolina, United States Indivior Full time

POSITION: Product Quality Validation Manager

Reporting To: Head of Global Quality Validation and R&D

Company Overview: Indivior is a worldwide specialty pharmaceutical organization committed to assisting individuals in overcoming addiction and mental health challenges. Our mission is to deliver evidence-based solutions for substance use disorders on a global scale. As a Product Quality Validation Manager, you will be instrumental in safeguarding the quality and safety of our pharmaceutical offerings.

ROLE SUMMARY:

  • Act as a subject matter authority in Quality validation concerning the product
  • Engage with interdisciplinary teams to address GxP-related challenges
  • Guarantee product adherence through Quality by Design methodologies
  • Oversee all facets of GMP Compliance and Quality validation
  • Supervise validation contractors and external service providers
  • Perform risk assessment and root cause evaluations
  • Additional duties as assigned

ESSENTIAL QUALIFICATIONS:

  • Bachelor's degree in a life science or engineering discipline
  • A minimum of 7 years of experience in Validation and Quality Assurance
  • Background in the pharmaceutical, biologics, or medical device sectors
  • Familiarity with regulatory standards and validation protocols
  • Prior experience with technology transfer and process validation
  • Excellent interpersonal and communication abilities

KEY COMPETENCIES:

  • Strong organizational and planning capabilities
  • Experience in managing validation initiatives
  • Proficient in English; knowledge of additional languages is advantageous
  • Driven by the goal of delivering high-quality patient care

EMPLOYEE BENEFITS:

  • Comprehensive medical, dental, vision, and life insurance plans
  • Tuition reimbursement and support for adoption
  • Employee stock purchase program and 401(k) matching
  • Flexible spending options for health and dependent care
  • Commitment to guiding principles, core values, and employee development

DIVERSITY AND INCLUSION:

Indivior is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.



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