Amgen Product Complaint Risk Facilitator in Thousand Oaks, California

The PQS (Product Quality Surveillance) Risk Facilitator will provide broad support to the Global Quality Systems teams as needed with a core focus on Product Quality Complaint Risk Management. This position will play a leading role in managing the execution of risk management initiatives including the facilitation of risk assessments on Amgen's products with key subject matter experts including but not limiting to: Safety, Device Engineering, Device Quality and Product Quality Leaders. The PQS Risk Facilitator will play an integral role in the classification of product complaint risk and on-going maintenance of the Product Complaints Risk Matrix. This is a highly visible role with global responsibility and cross-functional influence that has an impact on departmental performance and broad quality initiatives requiring primarily tactical decision making.

Day to Day Responsibilities:

Facilitate risk assessment sessions Develop and document business processes in the form of process flows, SOPs/business practice documents, and templates Track, monitor and update team goals, metrics, performance boards and reports Administration of Risk Management Training program Administration (if necessary) of Risk Assessment Route risk assessment requests and ensure facilitator assignment Supports the development of and approves the risk assessment summary reports

Responsibilities:

  • Assist with risk identification, tracking and planning for mitigation of risks

  • Facilitate risk assessment sessions

  • Develop and document business processes in the form of process flows, SOPs/business practice documents, and templates

  • Track, monitor and update team goals, metrics, performance boards and reports

  • Administration of Risk Management Training program

  • Administration (if necessary) of Risk Assessment

  • Route risk assessment requests and ensure facilitator assignment

  • Supports the development of and approves the risk assessment summary reports

Basic Qualifications:

Doctorate degree

OR

Master's degree and 2 years of Life Sciences, Business, Operations or Industrial Engineering experience

OR

Bachelor's degree and 4 years of Life Sciences, Business, Operations or Industrial Engineering experience

OR

Associate's degree and 10 years of Life Sciences, Business, Operations or Industrial Engineering experience

OR

High school diploma / GED and 12 years of Life Sciences, Business, Operations or Industrial Engineering experience

Preferred Qualifications :

  • Bachelor's Degree in Life Sciences, Business, Operations or Industrial Engineering

  • 5 or more years biotech or pharmaceutical operations/manufacturing/process development experience

  • 5 or more years of direct experience in project management key support roles

  • Risk Management Facilitator with the ability to analyze data with critical problem solving capabilities

  • Product Complaint experience

  • Ability to interpret and evaluate data

  • Strong analytical and critical thinking, pattern recognition, and problem solving capabilities

  • Excellent interpersonal and influencing skills

  • Aptitude for leading a matrixed, cross-functional team of contributors

  • Comfortable dealing with senior management and across functions, global sites and disciplines

  • Ability to deal with ambiguity

  • Familiarity with Risk Assessment tools and methods

  • Demonstrated ability to work independently and without direct supervision; as well as ability to work in teams

  • Ability to develop practical solutions to complex challenges

  • Ability to manage and prioritize multiple and diverse projects

  • Ability to adapt and respond to a variety of activities/situations simultaneously

  • Excellent communication, interpersonal and organization skills, and strong attention to detail

  • Experience with Excel and PowerPoint

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 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.

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 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.