Manager Quality Complaints

In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

Manager Quality Complaints supervises a team of complaint investigators owning records with basic investigations, customer feedback records and records with limited information. Quality Manager Complaints ensures execution of the complaint process in compliance with company policies/procedures and regulatory requirements.

• Ensures execution of the quality complaint process in compliance with the applicable procedures, laws and regulations
• Ensures quality of tasks and complaint records
• Leads team initiatives/projects
• Establishes performance expectations and monitors for daily improvement
• Prioritizes workload as needed based on the changing incoming volumes or records
• Leads and mentors a team of complaint investigators, providing mentorship and support as needed
• Raises potential quality issues to management
• Monitors team's performance and oversight of staff's performance and development
• Assures training is continuously maintained
• Accountable for day-to-day operations of the staff members under their supervision
• Participates in audits and assessments as required, providing documentation and information on complaint management processes
• Develops a culture of continuous improvement and customer-centricity within the team

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of quality management, with focus on complaints handling experience OR
• Bachelors degree and 6 to 8 years of quality management, with focus on complaints handling experience OR
• Diploma and 10 to 12 years of quality management, with focus on complaints handling experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech, medical device or pharmaceutical industry
• Leadership skills and the ability to supervise multiple projects simultaneously
• Familiarity with advance project management tools
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience in driving decision making by using DAI principles
• Understanding of quality and industry requirements/expectations of a QMS
• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Proven ability to lead cross-functional teams, consistently deliver timely, and high-quality results
• Build rapport with customers and colleagues to develop a collaborative environment.
• Ability to handling disagreements and finding resolutions that satisfy both parties.
• Adjust strategies and approaches based on the specifics of each complaint. Ability to work optimally with global, virtual teams.
• Grasp reputability and steering through regulatory guidelines and compliance obligations.
• View issues from the customer's perspective to better understand their concerns.
• Ability to travel +/- 20% of time to domestic and international Amgen sites

Note: This role may require working in shifts or extended hours within the same shift