Amgen Sr Manager Quality in Thousand Oaks, California
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.
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 may 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.
This individual will assist and/or perform supplier audits, which could require up to 25% travel for on site audits. This individual will provide process ownership of a number of different elements within our validation process, which could include activities associated to data integrity, supplier quality management, computerized systems validation, deviation/CAPA, and system development lifecycle.
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
Master’s degree and 6 years of quality experience
Bachelor’s degree and 8 years of quality experience
Associate’s degree and 10 years of quality experience
High school diploma / GED and 12 years of quality experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Supplier quality management and audit experience.
Oversight of processes related to data integrity, supplier quality management, computerized systems validation, deviation/CAPA management and system development lifecycle management. Work with 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 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
Forecasts, models and utilizes advanced analytical tools
Anticipates and prevents potential problems
Perform supplier audits and supplier quality management activities (potentially up to 25% travel for site audits)
May be responsible for specific programs and/or projects
Independently develops solutions that are thorough, practical and consistent with functional objectives
Establish/Improve training curriculum
Provide Management Review Updates on Quality activites
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.
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.
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Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a “Partially Meets Expectations” or higher. Please visit our Internal Transfer Guidelines for more detailed information
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.