Senior Manager QA

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.

Senior Manager QA

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead a team of dedicated individuals responsible for the quality oversight of commercial manufacturing at Amgen Rhode Island. This role demands a proactive and autonomous leader with an overall understanding of quality, compliance, and operations.

The Sr. Manager of Plant Quality Assurance (PQA) plays a critical role supporting commercial production, volume driven growth and advancing strategic priorities in Amgen Rhode Island (ARI). The Plant Quality Assurance team provides 24 hour, 7 day a week coverage of the AR30 manufacturing operations. The team works on the floor and interacts broadly across the site, which provides visibility and opportunity to influence outside of your function.

Key responsibilities include:

• Provide oversight to PQA daily operations, ensuring the team is supporting deliverables and following guidelines for general policies

• Represent Quality Assurance on incident triage teams by providing guidance and technical leadership for key decision making

• Partner with clients and stakeholders at various management levels across the organization to resolve issues, maintain compliance and ensure inspection readiness

• Collaborate with Quality peers to drive improvement and align at site and network level.

• Develop agile and resilient Quality professionals

• Develop and monitor functional areas goals in alignment with site and network strategic priorities

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience OR

• Associate degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR

• Bachelor’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR

• Master’s degree and 6 years of Quality, Manufacturing, Process Development or Process Engineering experience OR

• Doctorate degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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:

• Previous management experience with multi layered teams

• Demonstrated abilities in problem solving

• Excellent written and verbal communication skills

• Strong collaboration and partnership skills at various levels of management

• Understanding of quality management systems

• Proven ability to negotiate cross functionally and make informed risk-based decisions

• Experience with regulatory inspections

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.

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 n