Amgen Sr. Specialist/Manager Post Market Processes in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Let’s do this! Let’s change the world!
The Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our mission, to serve patients. This position will support the GPO of Post-market Actions in the creation and maintenance of the systems for efficiently managing quality events post-market. This position sits in Corporate Quality and interacts with senior leadership. This position will also participate in other QMS tactical and strategic activities, as required.
This position is based in Thousand Oaks, CA but other Amgen sites and/or remote work may be considered.
Ensures post market event management quality process is effectively implemented E2E across the global Operations Network
Maintains assigned Integrated Product Surveillance (IPS) QS IS/IT solution for GPO areas of responsibility in compliance with all applicable global regulations and global Amgen specific requirements
Monitors GMP Surveillance and takes necessary actions to determine solutions to applicable new or revised regulatory requirements related to Complaint Management, Regulatory Deviation Reporting, and Recall Management
Builds and provides performance metrics demonstrating the health of the QMS elements owned and for the IPS QS IS solutions to assure service levels and function are acceptable, acting as an advisor to the GPO
Owns and acts upon performance metrics and process issues, implementing actions to drive continuous improvement and escalating to management for support as needed
Leads and coordinates critical activities to ensure compliance throughout the network: gap assessments, commitments, response to audit & inspection findings including CAPA, deviations, and change control.
Trains and coaches Network and SMEs on processes owned by GPO
Revises SOPs, guidance's, and training materials related to the assigned processes
Work with the GPO for the QS element that the IPS solution supports to assure alignment, feedback from network, and global strategies
Supports regulatory inspections and audits with the technical defense of IPS solutions and supported processes
Supports continuous process improvements and partners with network SME’s on key initiatives
Manages external contractors providing standardized QS document processing, metric reporting, as indicated
Leads continuous process improvements and partners with network SME’s on key initiatives
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 these qualifications.
Master’s degree and 3 years of Quality experience
Bachelor’s degree and 5 years of Quality experience
Associate’s degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Positive, patient centered focus; in-depth appreciation of the value of teamwork
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 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
Experience in a pharmaceutical/drug/device manufacturing environment
Experience in project management and process improvement
Strong problem solving and data driven analytics
Knowledge of cGMP regulations (FDA, EMEA, TUV, Health Canada) and industry standards (ISO, ICH, PICs)
Experience presenting/managing regulatory inspections and audits
4 years of leading quality initiatives or processes across a global network
Basic knowledge of manufacturing operations
5+ years of leadership experience managing teams across global sites and functions
Ability to lead cross functional teams including sites, functions and regions across a global network of SME’s
Working knowledge Quality Management Systems
Ability to balance and interpret global priorities and market appropriate requirements to ensure Quality System elements are Agile and phase appropriate
Autonomous problem solver, willing to take informed and appropriate risks
Internal Candidates: Broad knowledge of the Amgen Quality Management System (QMS)
Understand global, regional and local commercial business (speak commercial)
Cultural awareness and dexterity
English language fluency- other language skills are an advantage
Innovation attitude with aptitude for developing ideas into meaningful objectives
Some of the vast rewards of working here
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.
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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with 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.
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.
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.