Senior Manager Quality Complaints

What you will do

Lets do this. Lets change the world. 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.

The Senior Manager Quality Complaints oversees the complaint management process ensuring compliance with company policies/procedures and regulatory requirements. Senior Manager Quality Complaints supervises a team of Complaint Investigators/Managers conducting standard and advanced investigations and implementing process improvement initiatives.

• 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 guidance 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
• Fosters a culture of continuous improvement and customer-centricity within the team
• Leads the development of strategies/reasons of internal team or cross functional initiatives/projects (e.g., Operational Excellence, Productivity, Continuous Improvement) including project timelines and priorities
• Owns and maintains workforce models, training plans, and staff recruiting onboarding/offboarding

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 2 years of quality management experience, with focus on complaints handling OR
• Masters degree and 8 to 10 years of quality management experience, with focus on complaints handling OR
• Bachelors degree and 10 to 14 years of quality management experience, with focus on complaints handling OR
• Diploma and 14 to 18 years of quality management experience, 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 oversee multiple projects simultaneously
• Ability to successfully manage workload to timelines
• 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
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
• Building rapport with customers and colleagues to foster a collaborative environment.
• Ability to managing disagreements and finding resolutions that satisfy both parties.
• Adjust strategies and approaches based on the specifics of each complaint. Ability to work effectively with global, virtual teams.
• Grasping reportability 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.