QA Manager, Site Lead

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds

leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live

What you will do

Lets do this! Lets change the world!

Amgen is searching for a Quality Manager Site Lead who will be responsible for Quality and Compliance Oversight of the External Supplier, this may include contract testing laboratories, contract manufacturing sites or raw material suppliers. The Manager will have responsibility working with supplier quality and manufacturing.

Key Responsibilities

• Serve as the main Quality point of contact related to Amgen product at External site

• Lead External site to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements

• Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses

• Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site

• Provide quality oversight of the manufacturing, testing, and release of Amgen products at External site

• Author and drive measurable site inspection readiness plans

• Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site

• Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required

• Identify and mitigate risk at the External site

• Monitor and communicate site performances in means of quality metrics through measurable periodic reviews and operating reviews

• Call out risks or roadblocks to management

• Drive timely decision-making using DAI principles

• Drive continuous improvements and Amgen first mentality

• Perform tactical batch disposition activities in support of lot release

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Masters degree and 2 years of Quality and/or Manufacturing experience

Or

Bachelors degree & 4 years of Quality and/or Manufacturing experience

Or

Associates degree & 10 years of Quality and/or Manufacturing experience

Or

High school diploma / GED & 12 years of Quality and/or Manufacturing experience

Preferred Qualifications:

• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelors Degree in a Science Field

• cGMP Experience

• Ability to lead all aspects of multiple projects simultaneously

• Able to successfully handle workload to timelines

• Familiarity with basic project management tools

• Ability to negotiate a position after taking feedback from multiple sources

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrix or team environment

• Ability to handle diverse relationships

• Ability to lead and manage cross-functional teams

• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

• Ability to travel +/- 10% of time to domestic and international Amgen/External sites

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

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

• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

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

careers.amgen.com

#Operations21
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.