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.
Director Information Systems - Quality Management Systems Product Owner - US Remote
Amgen is undertaking a multi-year initiative to implement a new Quality Management System (QMS). This project will undertake a comprehensive redesign to simplify and optimize our QMS by integrating fit for purpose processes and procedures across the enterprise. In parallel, it will implement a single, unified Veeva QMS platform coordinated with other core Amgen platforms delivering a consistent, simple, mobile ready user experience with sophisticated automation and analytics capabilities. In addition, the Digital QMS Initiative is expected to be the pilot for a new Risk Based Validation approach aligning with industry trends and revised agency guidance.
What you will do
Lets do this. Lets change the world. In this vital role you will own the design and delivery of the Veeva QMS product within this large multi-functional initiative.
As a Director Information Systems, you will:
Partner with Global Quality to define efficient, optimized, and industry best practiced processes such as Deviation, CAPA, Change Control and Batch Release
Lead a team of DTI Business Analysts responsible for detailing user requirements, supporting iterative releases of the product design, and testing of the system against business expectations
Owning the overall cross-process user requirements and product configuration ensuring each are forward thinking allowing for seamless addition of new capabilities including Veeva releases and advanced analytics
Identify and deploy automation opportunities across the Quality processes in scope of Digital QMS using Veeva QMS tools and external automation tools
Drive completion of tasks consistent with overall initiative timelines specifically related to user requirements, product configuration, release management and system testing
Collaborate with Digital QMS Validation and QA Leads to define the appropriate level of altitude for user requirements and design specs to fully use the latest industry trends in risk-based validation and Software Quality Assurance (SQA)
Ensure reliability and compliance of the QMS system while also driving continuous improvements and the long-term strategy and roadmap for this critical capability for Amgen, in partnership with the relevant stakeholders.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Digital Quality professional we seek is a leader with these qualifications.
Doctorate degree and 4 years of Information Systems experience
Masters degree and 8 years of Information Systems experience
Bachelors degree and 10 years of Information Systems experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
10+ years leading the design and management of user requirements on large, multi-functional global systems
5+ years in a Product Owner role within a regulated environment
Experience within a matrixed environment with direct leadership of technical resources and ability to effectively build relationships across multiple levels of DTI and Quality
Experience applying Veeva QMS across multiple enterprise level Quality processes in a large bio/pharma setting
Deployment of automation and sophisticated analytics technology tools to streamline processes
Solid grasp of the latest industry trends related to Computer System Assurance (CSA) and recent regulatory agency guidance specifically related to cloud-based solutions (SaaS) and risk-based validation
Experience working in and leading agile practices and methodologies including Scaled Agile Framework (SAFe)
Demonstrated excellence in verbal and written communication at all organizational levels
Solid project management, customer service, and conflict resolution skills
Ability to work independently and efficiently, managing timelines and expectations, and producing high-quality work (documentation, presentations, proof-of-concepts, etc.)
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $176,323. 205,564.
In addition to the base salary, 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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 cancers, 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.
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.