Senior Manager - Management Responsibilities GPO
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Live
What you will do
Lets do this! Lets change the world!
The Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our biggest mission, to serve patients. This highly visible position will lead efforts to assure our quality management system (QMS) is suitable, adequate, and effective. This position will participate in the transformation of the QMS towards our One QMS ambition: a single, central, simple quality system that works for all product types and all lifecycle phases. This position sits in Corporate Quality Systems, collaborate with executive leadership, and is involved with the QMS strategy.
This position is eligible for remote work.Responsibilities:
Owns the Quality Manual, Management Review, and Standards processes. Also owns the Process Overview and Multisite SOPs for these . Assures alignment with document hierarchy and document templates
Coordinates and compiles the QLT and Corporate level management review to assure senior leadership can maintain a suitable and effective QMS.
Assure senior and executive management roles expectations are cear, assigned, and documented
Owns and acts upon performance metrics and process issues, implementing actions to drive continuous improvement and raising to management for support if needed
Leads and coordinates critical activities to ensure compliance throughout the network: gap assessments, commitments, response to audit & inspection findings and deviations
Leads continuous process improvements and partners with network SMEs on key initiatives
Supports regulatory inspections and audits
Maintains assigned global quality process in compliance with all applicable global regulations and global Amgen specific requirements
Monitors GMP Surveillance and takes vital actions to align process to applicable new or revised regulatory requirements
Leads network and cascades requirements and QMS architecture down to all applicable sites and functions. Advises sites early of changes to ensure consistencyWin
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.Basic Qualifications
Doctorate degree and 2 years of Quality experience
Masters degree and 6 years of Quality experience
Bachelors degree and 8 years of Quality experience
Associates degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
2 years of managing a global network team and broad Pharmaceutical, Medical Device, or Combination Product experience.Preferred Qualifications
5+ years managing Quality professionals s
Leadership experience in a pharmaceutical/combination products/device at a corporate level
Experience leading medium or large projects at a global level
Experienced in Agile Quality Systems and Continuous Improvement Tools
4+ years managing Quality professionals or project manager
Ability to build, maintain, prioritize and present QMS improvement strategy
Autonomous problem solver, willing to take informed and appropriate risks
Broad and deep knowledge of the Amgen Quality Management System (QMS)
Understand global, regional and local commercial business (speak commercial)
Understanding of Amgens strategy and organizations
Innovation, Agile mentality with aptitude for developing ideas into measurable objectives
Other language skills
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com#Operations21Equal 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.
Join UsIf 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.