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.

Manager Quality Complaints

What you will do

Let’s do this. Let’s change the world. In this vital role you will be a 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.

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 guidance and support as needed

• Escalates 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

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 4 to 6 years of related experience in quality management, with focus on complaints handling experience OR

• Bachelor’s degree and 6 to 8 years of related experience in quality management, with focus on complaints handling experience OR

• Diploma and 10 to 12 years of related experience in quality management, with focus on complaints handling experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech, medical device or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Leadership skills and the ability to be responsible for multiple projects simultaneously

• Ability to efficiently handle 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 cross-functional teams, consistently deliver timely, and high-quality results

• Establish trust 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 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.

What you can expect of us

As we work to develop treatments that deal with 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.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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