Career Category

Job Description

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. Join us.

Live

What you will do

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

At Amgen, our mission is simple: to serve patients. Our new Tampa Capability Center provides essential services that enable us to better pursue this mission. This state-of-the-art center serves as a base for finance, information systems, and human resources professionals to make a meaningful impact at one of the world’s leading biotechnology companies.

The Sr. Manager Quality Assurance will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques and procedures. In this position you will monitor validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.

This individual will supervise staff who actively participate during all phases of qualification/validation: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.

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.

Doctorate degree and 2 years of quality experience

Or

Master’s degree and 6 years of quality experience

Or

Bachelor’s degree and 8 years of quality experience

Or

Associate’s degree and 10 years of quality experience

Or

High school diploma / GED and 12 years of quality experience

And

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

Responsibilities:

Supervise a diverse team of Quality Professionals which span multiple time zones. Review validation/qualification packages for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes.

Participation and support of regulatory inspections. The following are examples of execution tasks for this position:

• Develop, Mentor, and oversee staff and day to day validation activities

• Act as reviewer and approver for operational SOP’s and Work Instructions

• Review of operational SOP’s and Work Instructions

• Review and approve change controls and Deviations/CAPA/CAPA EVs

• Initiate and own QA Deviations/CAPA/CAPA EVs as needed.

• Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.

• Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information

• Qualitative information

• Quantitative research

• Trend data

• Forecasts, models and utilizes advanced analytical tools

• Anticipates and prevents potential problems

• May be responsible for specific programs and/or projects

• Independently develops solutions that are thorough, practical and consistent with functional objectives

• Maintain budget

• Establish/Improve training curriculum

• Provide Management Review Updates on Quality activites

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.

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Equal 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.