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Head of Operations Quality Information Systems
at Amgen Inc.
Career CategoryInformation Systems
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering creative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Main Job Purpose:
Amgen is seeking a Head of Quality Information Systems (IS) to join the Operations IS (OIS) organization at its main headquarters in Thousand Oaks, CA. You will act as the OIS leader supporting Quality and will be a member of the OIS Leadership Team and Quality Leadership Team, contributing to Quality and Information Systems strategic directions. As IS leader for Quality, accountable for all strategic technology planning/road-mapping, operational run and building of new capabilities supporting the function globally, including Thousand Oaks, and all of Amgen’s global Operations sites.
OIS is accountable for the delivery of the information and Operations technology systems that enable the successful development, design, manufacturing, distribution and commercialization of Amgen products. OIS is responsible for the development and execution of the IT strategy, architecture and operations by delivering business information systems, IT services and digital technology solutions and devices.
This role supports many functions within Quality and characterized with these three key areas. First, Corporate Quality Systems that encompasses management of deviations, changes, corrective actions, documentation as well as product complaints. Next, Quality Control partnering with our lab functions supporting analytical testing, sample and stability management, and finally disposition. Finally, Environmental Health and Safety including risk management, design, and occupational health.
You will report to the Head of Operations Information Systems (OIS) and will partner with other parts or the organizations to advance the quality digitalization and modernization efforts. This person will also transform the IS Quality processes by coordinating and driving the planning & road-mapping efforts to transform the business.
Key Activities for the Head of Quality Information Systems include:
- Be responsible for the Digital Quality Program to set a preventable and predictable quality system. Drive the business transformation while providing strategic leadership and drive tactical execution.
- Drive strategic direction of the Laboratory Information Management and Quality Management Systems replacements.
- Setup and lead a lifecycle program across all areas
- Own the application and evolution of Amgen Operations Information Systems S95 blueprint and technical architecture to the manufacturing of the Future Facility Requirements
- Actively define and run the annual IS project portfolio for Quality and oversight of long term run support of solutions implemented
- Provide direct management to a team of up to ten people coordinating their activities, progress towards goals, and career development.
- Provide technical & program/project leadership to the project teams in all project phases (design, delivery, startup, commissioning, validation and operational support) as well as IS leadership oversight to ensure the program/project budget, schedule and staffing is commensurate to enabling the manufacturing automation and information systems to attain the performance standards required to support the business objectives
- Influence the development of business area strategy where appropriate
- Direct efforts of Information Systems integrators, vendors, contractors, and Amgen teams in the successful execution of efforts by using appropriate development methodologies to meet Operations' business requirements
- Travel: Domestic and International travel up to 20% may be critical
Doctorate degree and 4 years of Information Systems experience
Maste'rs degree and 8 years of Information Systems experience
Bachelor's 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
Preferred Qualifications :
- Validated overseas/international experience
- Experience working with senior IS and C-level Business executives
- Proven working knowledge with the following:
- GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards
- Manufacturing information systems in cGMP regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validation
- Enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering
Experience with the following:
- Experience in quality management and quality control in clinical and commercial manufacturing
- Quality Management systems, Trackwise or similar.
- Other areas of Information Systems supporting manufacturing business unit
- Strong program leadership skills, including but not limited to the following: client interfacing and resolution of business partner concerns, developing and reporting results, technical mentorship, detailed planning, vendor/contract management, validation, technical solution evaluation.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
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.
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.