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Amgen Inc

Manager Quality Complaints

3-6 Years
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Job Description

  • Ensure execution of the quality complaint process in compliance with procedures, laws, and regulations.
  • Maintain high quality in complaint records and related tasks.
  • Lead team initiatives and projects focused on process and performance improvement.
  • Establish clear performance expectations and drive daily improvement.
  • Prioritize workload based on changing volumes and record flow.
  • Lead and mentor complaint investigators, offering guidance and support.
  • Raise potential quality issues to management promptly.
  • Monitor and oversee team and individual staff performance and development.
  • Ensure ongoing training and compliance with quality standards.
  • Manage daily operations of complaint handling team.
  • Participate in audits and assessments by providing necessary documentation and process knowledge.
  • Foster a culture of continuous improvement and customer focus.

Basic Qualifications:

  • Doctorate degree
  • OR
  • Master's degree with 4–6 years of quality management (focus on complaint handling)
  • OR
  • Bachelor's degree with 6–8 years of relevant experience
  • OR
  • Diploma with 10–12 years of relevant experience

Preferred Qualifications:

  • Quality and manufacturing experience in biotech, medical device, or pharmaceutical industry
  • Strong leadership and multitasking skills across projects
  • Familiarity with advanced project management tools
  • Ability to work effectively in a matrixed/team environment
  • Experience applying DAI (Decision, Alignment, and Integration) principles
  • Knowledge of QMS requirements and manufacturing/testing processes (e.g., API, Drug Product, Packaging)
  • Strategic negotiation skills and cross-functional leadership experience
  • Strong rapport-building and conflict-resolution abilities
  • Adaptable complaint-handling strategies based on unique scenarios
  • Global collaboration and regulatory compliance navigation
  • Customer-first mindset and issue resolution perspective
  • Willingness to travel up to 20% domestically/internationally

More Info

Job Type:
Function:
Employment Type:
Open to candidates from:
Indian

About Company

Job ID: 111858055

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