22 days old

Manager Quality Complaints

Amgen
Thousand Oaks, CA 91360
  • Job Code
    124580203
Amgen

Job ID: R-105286
Location: Thousand Oaks, CA, US

Job Summary

Amgen is seeking a Manager Quality Complaints and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Manager leads a team responsible for driving compliant triage, processing, and documentation of customer complaints for Amgen products. Assures complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. Utilizing daily management tools, provides prioritization guidance and aligns workload across the team.

Key Responsibilities:
  • Establishes performance expectations and monitors for daily improvement
  • Leads team's performance and oversight of staff's performance and development
  • Ensures quality of tasks and complaint records
  • Ensures execution of regulatory and SOP requirements
  • Conducts complaint investigations as appropriate
  • Sets record timelines and priorities
  • Provides guidance and technical advice
  • Escalates potential Quality issues to senior management
  • Provides input to financial oversight / team's budget management
  • Drives Operational Excellence and champions change


Basic Qualifications

Doctorate degree

OR

Master's degree & 3 years of Quality / Manufacturing experience

OR

Bachelor's degree & 5 years of Quality / Manufacturing experience

OR

Associate's degree & 10 years of Quality / Manufacturing experience

OR

High school diploma / GED & 12 years of Quality / Manufacturing experience

Preferred Qualifications
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's Degree in a Science Field
  • Leadership skills
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience in driving decision making by using the decision-making principles
  • Understanding of quality requirements
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

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.

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.



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Posted: 2020-10-07 Expires: 2020-11-07

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Manager Quality Complaints

Amgen
Thousand Oaks, CA 91360

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