Manager Quality Assurance

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.

Manager Quality Assurance

What you will do

Let’s do this! Let’s change the world! In this vital role you will lead our B7 QA team supporting EPO manufacturing with responsibilities of ensuring the quality and compliance of the medicine we manufacture.

Responsibilities:

• Manage and develop a team of QA professionals, providing guidance, coaching, and performance evaluation

• Establish and maintain quality standards, policies, and procedures in accordance with regulatory (FDA), local, and corporate requirements

• Supervise and audit the process, material, and product testing against established specifications and acceptance criteria

• Conduct root cause analysis and implement corrective and preventive actions for quality issues and deviations

• Review and approve quality documents, such as protocols, reports, SOPs, change controls, deviations, CAPAs, and OOS investigations

• Collaborate with cross-functional teams, such as R&D, Manufacturing, Engineering, Validation, and Regulatory Affairs, to ensure quality alignment and support

• Lead or participate in internal and external audits and inspections, as well as vendor qualification and oversight

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 3 years of quality assurance or quality control experience OR

• Bachelor’s degree and 5 years of quality assurance or quality control experience OR

• Associate’s degree and 10 years of quality assurance or quality control experience OR

• High school diploma / GED and 12 years of quality assurance or quality control experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• A bachelor’s degree or higher in Engineering, Science, or a related field

• Demonstrated ability in quality assurance or quality control in the biotechnology or pharmaceutical industry

• Experience in biologics production, testing, and release

• Knowledge of cGMPs, ICH guidelines, ISO standards, and other relevant regulations

• Strong leadership, communication, problem-solving, and analytical skills

• Proficiency in Microsoft Office and other quality software tools

What you can expect from 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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverag