Career Category

Compliance

Job Description

The Process Document Management (PDM) team, within the R&D Quality, Compliance, Audit, Learning and Performance (QCAL&P) organization, provides expert support for the creation and management of R&D controlled processes and documents. The team is responsible for the maintenance of R&D standards and contributing to the compliant execution of R&D processes through clear and appropriate controlled documentation. The PDM team also provides R&D oversight for the electronic document management system including enhancements and improvements.

The Compliance Manager will play a key role for the management of R&D controlled documents through helping to strengthen and advance Amgen’s R&D Quality Management System.   The Compliance Manager contributes to implementing strategies and providing leadership to ensure excellence in controlled document management.  As an integral team member working globally with QCAL&P team members and Business Process Owners to ensure compliance with regulations and other requirements through:

• Contributing to and implement strategies for R&D controlled document management.
• Establishing and implementing end-to-end processes and standards for controlled documents.
• Leading complex cross-functional documentation change and process improvement projects across R&D.
• Providing input and technical expertise to establish, implement, maintain and adapt document hierarchy.
• Executing controlled process creation/revision activities.
• Providing quality expertise and guidance to R&D functions and business process owners to ensure complete, clear and well managed documents.
• Leading targeted documentation review and improvement efforts.
• Partnering with process owners, training leadership and business process management to implement robust process documentation change control and communication strategies.
• Advancing process-document changes to address incidents, deviations, audit and inspection findings.
• Identifying opportunities for Enterprise Application implementations to ensure consistency across functional boundaries.

Basic Qualifications

Doctorate degree
OR
Master’s degree and 3 years of Quality/Compliance/Process Management experience
OR
Bachelor’s degree and 5 years of Quality/Compliance/Process Management experience
OR
Associate’s degree and 10 years of Quality/Compliance/Process Management experience
OR
High school diploma / GED and 12 years of Quality/Compliance/Process Management experience

Preferred Qualifications

• Advanced Degree
• Eight years in Quality Management, Compliance or related areas within the pharmaceutical/biotech industry
• Process management, documentation and modelling experience
• Proven experience in change and project management
• Knowledge of global regulations impacting R&D activities
• Quality Management System oversight and implementation experience
• Knowledge of controlled document management systems and Good Document Management practices

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 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.

.