QA Sr Mgr-Partnership and Alliance Quality

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Live

What you will do

Lets do this! Lets change the world!

In our mission to serve patients, speed is absolutely critical. Were rapidly expanding our hiring initiatives and are excited to unite with the most passionate and forward-thinking scientific minds who want to join our team working toward our mission of advancing high potential programs for cancer patients around the world.

The position serves as the Quality Alliance Lead and the primary Amgen Quality point of contact for coordination interactions with Amgen business partners.

Responsibilities include:

• Responsible for leadership and coordination of Quality as needed across Amgen, for interactions with business partners, Amgen sites, and corporate business units.

• Lead strategic negotiation, development and ongoing oversight of high-impact partnerships and alliances from a Quality perspective.

• Negotiate Quality Agreements and participate in the negotiation of relevant Supply agreements to ensure appropriate Quality requirements are defined.

• Participate in regulatory inspections as necessary relating to partnerships/alliances to ensure successful business outcomes.

• Coordinate and facilitate partner visits by business partner Quality representatives.

• Coordinate specific activities relating to audits of Amgen by business partners.

• Lead and manage partner Quality forums and Partner Annual Reviews.

• Collaborate with Business Development partners to ensure business priorities are successfully executed against.

• Participate in the development of new partner strategic plans and participating in the execution of application tasks to successfully accomplish project goals.

• Develop strong partnership with internal manufacturing network and relevant contract manufacturing sites to ensure alignment.

• Liaise with peers within the Quality organization to ensure continued evolution of Amgens Quality system are aligned with developing partnership and alliance needs.

• Responsible for the execution of projects necessary to achieve to achieve corporate and departmental goals.

• Ability to conduct and act upon thoughtful risk analysis. Knowledge of continuous improvement principles and experience in implementing continuous improvement efforts across a global team.

• Establish standard methodologies for completion of key tasks and drive continuous improvement activities.

Travel both domestically and internationally about 15%

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 will have these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 3 years of Quality experience

OR

Bachelors degree and 5 years of Quality experience

OR

Associates degree and 10 years of Quality experience

OR

High school diploma / GED and 12 years of Quality experience

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Staff member at GCF level 6

• 7-10 years experience (Manufacturing, Process Development, or Quality Assurance) in the pharmaceutical/biotech industry

• Experience involving the development of Quality Agreements and relationships with globally diverse partners

• Work in a team matrix environment and independently interact with various levels of management

• Direct experience with bulk manufacturing of biopharmaceuticals

• Demonstrated proficiency leading negotiations

• Excellent communication skills, both written and oral,

• Knowledge of Quality Assurance functions and practices

• Ability to evaluate and lead negotiations around Quality Agreements

• Experience in project management (managing projects, defining scope, tracking breakthroughs)

• Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes

• Appropriate cultural awareness and ability to work effectively with those from other cultures/countries

Thrive

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization

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

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

#OperationsEqual Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a 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 an accommodation.

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.