At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will do
Let’s do this. Let’s 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
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
Master’s degree and 8 to 10 years of quality management experience, with focus on complaints handling OR
Bachelor’s 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.
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.