HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

QA Senior Manager

Live

What you will do

Let’s do this! Let’s change the world!

The QA Sr Manager role is responsible for Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen cross-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process development, and supply chain.

Responsibilities Include:

• Quality liaison between Amgen and the supplier

• Negotiator and owner of quality agreements

• Prepare external site for inspections including development of inspection playbooks

• Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during notified body audits of supplier, as applicable or required

• Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas

• Review/Approve supplier investigations, events and change notifications

• Quality approver of deviations, change controls, CAPA, CAPA EVs

• Identify and mitigate risk at the supplier and/or escalate to management

• Perform Person in Plant activities, as deemed appropriate

• Drive audit commitments to completion

• Lead supplier audit preparation and identify areas of focus

• Continuously assess supplier status through periodic monitoring reporting

• Partner with Operations site lead on issues, improvements, site performance and overall relationship management

• Understand and implement GMP requirements internally and externally

• Up to 20% domestic and international travel required

• This role may work on-site at one of the following locations: Thousand Oaks, CA, Cambridge, MA, Greenwich, RI, or Puerto Rico

• Open to remote associates in any US location

Win

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 employee with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Quality or Manufacturing or Operations experience

Or

Master’s degree and 6 years of Quality or Manufacturing or Operations experience

Or

Bachelor’s degree and 8 years of Quality or Manufacturing or Operations experience

Or

Associate’s degree and 10 years of Quality or Manufacturing or Operations experience

Or

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

Preferred Qualifications:

• 10 + years biotech or pharmaceutical industry experience

• 5+ years of experience overseeing quality of suppliers

• Auditor Certification or experience performing audits

• Raw Material Compendial Testing proficiency

• Knowledge of Single Use Systems, Resins, and filters in an aseptic manufacturing facility

• Significant Quality experience at Aseptic Manufacturing facilities

• Able to facilitate and influence senior collaborators and partners

• Able to successfully manage workload and timelines

• Familiarity with basic project management tools

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

• Strong project management, problem-solving, and analytical skills

• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results

• Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution

• Ability to operate in a matrixed or team environment with site, functional, and executive leadership

Thrive

What you can expect of us

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

The annual base salary range for this opportunity in the U.S. is $136,995 - $156,890.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Apply now

for a career that defies imagination

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

careers.amgen.com

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 cancers, 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.

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.