Manager Quality Complaints

Career Category

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

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.

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

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 quality management, with focus on complaints handling experience OR

• Bachelor’s 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

What you can expect of us

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.

Apply now for a career that defies imagination

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

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.