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.

　　Senior Manager, Quality Control

　　Live

　　What you will do

　　Let’s do this! Let’s change the world! In this vital role you will lead a multi-layered team in the Amgen Rhode Island Quality Control organization responsible for microbiology testing of Amgen products and raw materials, environmental monitoring / utilities program, sample management and stability program storage.

　　Microbiology Team:

　　Be responsible for Environmental Monitoring and Utility Monitoring Programs

　　Provide input and direction for Contamination Response

　　Functional Area Owner for microbiology testing deviations

　　Support site and global initiatives

　　Own critical metrics for Center of Excellence Mycoplasma testing for the Network

　　Quality Control for Manufacturing Operations (2 shifts/ 7-day coverage):

　　Supervise scheduling of testing tasks to ensure uninterrupted business support

　　Support improvement efforts for Microbiology, TOC, Conductivity Testing

　　Functional Area Owner for testing platform deviations

　　Own critical metrics for Testing Platforms

　　Sample Management & Stability Team:

　　Be responsible for scheduling and management of Site Stability tasks

　　Supervise shipping/receiving for samples

　　Functional Area Owner for stability processing and shipment deviations

　　Lead Contract Test Lab sample lifecycle (purchase orders to results)

　　Be responsible for LIMS Lot Authorization and on-time lot disposition results

　　Quality Control Leadership Team:

　　Representation in governance, management review and other forums.

　　Innovative projects to advance productivity.

　　Compliance with safety guidelines, cGMPs and other applicable regulatory requirements.

　　Support staff training, career development and performance management.

　　Establish and enable LEAN principles across all areas of responsibility.

　　Establish and enable department goals, strategies and important metrics.

　　Additional Responsibilities:

　　Effectively leads the daily work of direct reports responsible for various QC functions.

　　Champions process improvements that have major implications to Laboratory operations as it relates to site production and the Amgen network.

　　Mentor employees by sharing technical expertise and providing feedback and guidance.

　　Understands business environment and relates extensive knowledge of industry to streamline business processes.

　　Interfaces with management on significant matters, often requiring the coordination of activity across organizational units and exercises judgment independently.

　　Plans and organizes project assignments of substantial variety and complexity.

　　Initiates or maintains schedule to support QC, network and production requirements.

　　Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

　　Clearly articulate and educate others sampling, testing and release, sample management, business processes, regulatory and compendia requirements.

　　Translates complex data into actionable information and applies strong technical knowledge to meet business objectives Consistently applies a systematic approach and uses exemplary analytical and critical thinking skills for problem solving.

　　Identifies process gaps, introduces innovative solutions, and leads operational excellence projects to improve efficiency and productivity, while decreasing expense/operating costs.

　　Leads root cause analysis discussions for more sophisticated problems to develop and efficiently implement effective permanent solutions.

　　Generates passion, energy, and commitment by expressing a compelling idea or goal. Seeks out opportunities to permanently improve processes and shares standard methodologies with others.

　　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 a leader with these qualifications.

　　Basic Qualifications:

　　High school diploma / GED and 12 years of Quality Control experience OR

　　Associate’s degree and 10 years of Quality Control experience OR

　　Bachelor’s degree and 8 years of Quality Control experience OR

　　Master’s degree and 6 years of Quality Control experience OR

　　Doctorate degree and 2 years of Quality Control experience

　　In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or advising the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

　　Preferred Qualifications:

　　Solid understanding of cGMP regulations, practices, and trends pertaining to Quality Control.

　　Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources

　　Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners

　　Track record of building or participating as a member of high performing team

　　Experience in leading and owning sophisticated investigations.

　　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

　　Understanding of quality management systems and quality control processes related to drug substance and drug product for clinical and commercial operations

　　Proven ability to navigate through ambiguity and provide structured problem solving

　　Proven ability to coordinate multi-functional project teams and deliver on schedule

　　Proven ability to coordinate and lead cross-functional teams

　　Proven ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization

　　Proven skills in staff motivation, coaching/mentoring and professional development

　　Great teammate who is able to collaborate and provide leadership through influence to achieve the required results

　　Thrive

　　What you can expect of us

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

　　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

　　Apply now for a career that defies imagination

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

　　careers.amgen.com

　　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 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.