Manager Quality Complaints
In this vital role, you will own and implement the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. The focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to meet current and emerging internal and external requirements. Additionally, the team translates information from the market to drive continuous improvement.
Roles & Responsibilities:
- Ensure execution of the quality complaint process in compliance with the applicable procedures, laws, and regulations
- Ensure quality of tasks and complaint records
- Lead team initiatives/projects
- Establish performance expectations and monitor for daily improvement
- Prioritize workload based on changing incoming volumes or records
- Lead and mentor a team of complaint investigators, providing guidance and support
- Raise potential quality issues to management
- Monitor team performance and provide oversight on staff performance and development
- Ensure continuous training is maintained
- Be accountable for day-to-day operations of supervised staff members
- Participate in audits and assessments, providing documentation and information on complaint management processes
- Develop a culture of continuous improvement and customer-centricity within the team
Basic Qualifications:
- Doctorate degree
- OR
- Master's degree and 4 to 6 years of quality management experience, focused on complaints handling
- OR
- Bachelor's degree and 6 to 8 years of quality management experience, focused on complaints handling
- OR
- Diploma and 10 to 12 years of quality management experience, focused on complaints handling
Preferred Qualifications:
- Quality and manufacturing experience in biotech, medical device, or pharmaceutical industry
- Leadership skills with ability to manage multiple projects simultaneously
- Familiarity with advanced project management tools
- Experience working in a matrixed or team environment with site, functional, and executive leadership
- Experience using DAI (Decision-making Accountability and Integrity) principles
- Strong understanding of quality and industry expectations for Quality Management Systems (QMS)
- Familiarity with manufacturing/testing processes such as API, Drug Substance, Drug Product, Packaging, and Device manufacturing
- Strategic negotiation skills with the ability to incorporate feedback from multiple stakeholders
- Proven ability to lead cross-functional teams and deliver timely, high-quality results
- Customer-centric mindset with ability to build rapport and maintain a collaborative environment
- Conflict resolution skills and ability to adapt strategies based on complaint specifics
- Ability to function effectively within global, virtual teams
- Deep understanding of regulatory guidelines and compliance obligations
- Empathy and customer perspective when handling complaints
- Willingness and ability to travel up to 20% domestically and internationally
- Availability to work in shifts or extended hours within the same shift
