Manager Quality Complaints

3 weeks ago


Hyderabad, Telangana, India Amgen Inc Full time
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 46 years of quality management (focus on complaint handling)
- OR
- Bachelor's degree with 68 years of relevant experience
- OR
- Diploma with 1012 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

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