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Job Description

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.

Live

What you will do

Let’s do this. Let’s change the world.

Job Description

The Director Corporate Quality GxP Computer Systems and Data Integrity will serve as a leader of the Corporate Quality GxP team, a multi-discipline group that plans, implements, and supports GxP Computer Systems, Validations and Data Integrity solutions for Operations at Amgen.

Responsibilities:

• Integrate Amgen's quality and compliance management practices with the enterprise-wide computing system.

• Lead a team that will participate on working teams to implement new and updated computerized systems and liase between Quality and other key collaborators.

• Lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques and procedures.

• Serve as SME for successful interaction with FDA and other regulatory bodies during site inspections.

• Develop and conduct appropriate training to ensure Company-wide awareness of Computer Systems Validation and Regulatory requirements

• Ensure Incorporation of Phase Appropriate Activities for Qualification/Validation while simplifying approaches and maintaining use of programs (i.e. boundary diagrams, change control, paperless Maximo based ‘fit for use/qualification processes) for Global Business Applications, Lab Equipment, Equipment and Automation Systems across R&D, Operations, and IS

• Develop and maintain quality system standards and procedures for computer systems to GxP regulations

• Develop and track metrics to monitor the health of computerized systems as it relates to data integrity and validation and report to management

• Develop phase and risk appropriate validation based on use of system

• Perform industry benchmarking on computerized systems compliance to keep abreast of the everchanging regulatory landscape.

• Develop validation/qualification package deliverables to ensure standardization across the network and compliance with validation policies and procedures including accurate data analysis.

• Responsible for hiring, mentoring, and developing team members.

• Deploy dedicated, information systems professionals working closely with colleagues to create innovative and effective information solutions.

• Work in a team matrix environment and independently interact with various levels of management to drive initiatives to completion globally.

• Work independently to define, lead and implement global improvements to quality systems for computerized systems as well as clearly communicate issues to senior management and affected staff.

• Serve as a resource to other functional areas in the appropriate use and management of GxP systems Partner with different site functions such as Manufacturing, Engineering, Quality, Executive Management and various support organizations to identify critical business requirements to develop the operations data integrity detection and assurance strategy.

• Promote the development of forums across departments and sites for training on system utilization and information exchange.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications

Doctorate degree and 4 years of Information Systems, Quality or Engineering experience

Or

Master’s degree and 8 years of Information Systems, Quality or Engineering experience

Or

Bachelor’s degree and 10 years of Information Systems, Quality or Engineering experience

And

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Demonstrated experience in Computer Validation and Data Integrity within a Quality or Operations organization in the Pharmaceutical, Medical device or Biotech Industries

• Demonstrated knowledge and expertise in quality management and quality control in clinical and commercial manufacturing

• Strong program leadership skills, including but not limited to the following: client interfacing and resolution of business partner concerns, developing and reporting results, technical guidance, detailed planning, vendor/contract management, validation, technical solution evaluation.

• Demonstrated ability to handle multiple competing priorities across different business units. Ability to communicate and collaborate with technical and management staff within Manufacturing, Information Systems, Process Development, and Quality.

• Experience at developing system migration and evolution strategies and turning the strategies into plans which are implemented.

• Ability to lead a cross functional global network on computer systems and data integrity.

• Demonstrated 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, ERP (SAP), Electronic Document Management, Trackwise and Laboratory Systems (LIMS, CDS, LMES)

Enterprise business systems delivery, support and service ownership in the areas of Manufacturing, Supply Chain, Quality, Laboratory, and Engineering

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 demonstrates 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.

Thrive

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.

careers.amgen.com