Manager Quality Assurance

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Manager Quality Assurance

Live

What you will do

Lets do this! Lets change the world! In this vital role, you will supervise a team responsible for QC Analytical and Quality Systems at Amgen Rhode Island, and will contribute to encouraging and further developing the culture of Safety, Quality, and Lean Leadership.

The QA Manager will contribute directly and provide oversight to a team responsible for the following functions in support of core QC laboratory operations:

• Site SMEs for Quality Control electronic systems including: Laboratory Information Management Systems (LIMS), Laboratory Method Execution System (LMES), Consumables Inventory Management Systems (CIMS), and Empower.
• Ownership of minor deviations and CAPA/EV records.
• Quality oversight of Analytical Result Assessment (ARA) and major deviation records.
• Generation of laboratory/method performance metrics and key performance indicators (KPIs)
• Site SMEs for sample plan management

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 outstanding communicator with these qualifications.

Basic Qualifications:

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

AND

• High school diploma / GED and 12 years of Quality experience OR
• Associates degree and 10 years of Quality experience OR
• Bachelors degree and 5 years of Quality experience OR
• Masters degree and 3 years of Quality experience OR
• Doctorate degree

Preferred Qualifications:

• Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources
• Experience with QC analytical systems and/or Quality systems
• Excellent interpersonal, written and verbal communication skills with all levels within the organization
• Ability to work in a team matrix environment and build relationships with partners
• Identify, lead, and champion innovative projects to advance efficiency and enable LEAN principles across different functions
• Experience with supporting staff training, career development and performance management through establishment and tracking of department goals, strategies and KPIs
• Experience in auditing and defending processes, procedures and decisions during regulatory inspections
• Experience with various laboratory computer systems and applications
• Strong leadership and negotiation skills with a demonstrated ability to influence different styles
• Demonstrated innovative thinking and ability to transform work organizations
• Strong technical writing skills within a highly regulated environment
• Exposure to Operational Excellence initiatives
• Proven ability to navigate through ambiguity and provide a structured problem solving
• Demonstrated ability to coordinate multi-functional project teams and deliver on schedule

Thrive

Some of the vast rewards of working here

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.

• 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.

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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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.