Sr Associate Quality Complaints
Amgen · Hyderabad, India
The apply link worked recently (not employer-confirmed).
Role summary
This senior-level quality role focuses on managing Amgen's global complaint processes and systems while ensuring compliance with quality standards. The position involves conducting complaint investigations, evaluating complaint records, and supporting continuous improvement initiatives. The candidate should hold a Master's degree with 4–7 years of quality experience, or a Bachelor's degree with 5–9 years in the field, preferably in biotech, pharma, or medical devices.
What they're looking for
- Master's degree with 4-7 years quality experience, or Bachelor's degree with 5-9 years
- Quality and/or manufacturing experience in biotech, pharmaceutical, or medical device industry
- Bachelor's degree in a science field preferred
- Understanding of quality management systems and industry regulatory requirements
- Knowledge of manufacturing and testing processes including API, drug substance, and drug product
- Ability to manage workload to timelines and work in matrixed team environments
- Experience applying data-driven decision-making principles and translating feedback into processes
What you'll be doing
- Own and implement end-to-end global complaint process management system ensuring regulatory compliance
- Conduct low to medium complexity complaint investigations and determine escalation requirements
- Evaluate complaint records for alignment with procedures and ensure quality standards
- Complete assessments and implement complaint processes per standard operating procedures
- Support project management tasks including communication, status tracking, and tool maintenance
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.