Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

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

Amgen is seeking a Senior Manager Quality Complaints and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns 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 supervises the complaint management process ensuring compliance with company policies/procedures and regulatory requirements. Sr Manager Quality Complaints supervises a team of Complaint Investigators/Managers conducting standard and advanced investigations and implementing process improvement initiatives.

Responsibilities:

• 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 technology as needed based on the changing incoming volumes or records
• Leads and mentors a team of complaint investigators, providing guidance and support as needed
• Brings up 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
• Leads the development of strategies/cases of internal team or multi-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

Basic Qualifications:

• Doctorate degree & 2 years of directly related experience in quality management, with focus on complaints handling OR,
• Master’s degree & 8 to 10 years of directly related experience in quality management, with focus on complaints handling OR,
• Bachelor’s degree & 10 to 14 years of directly related experience in quality management, with focus on complaints handling OR,
• Diploma & 14 to 18 years of directly related experience in quality management, with focus on complaints handling
• Fluency in verbal and written English to be able to understand & articulate technical concepts

Preferred Qualifications:

• 8+ years of quality and manufacturing experience in biotech, medical device or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• Leadership skills and the ability to supervise 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
• Proven ability to lead multi-functional teams, consistently deliver on-time, and high-quality results
• Building rapport with customers and colleagues to develop a collaborative environment.
• Ability to leading 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.

Thrive
 

What you can expect of us

• As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Vast opportunities to learn and move up and across our global organization

• In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability
status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits
and privileges of employment. Please contact us to request accommodation.

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