Amgen

QA Sr. Manager - Device Site Lead

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 29, 2019
Ref
R-78946
Required Education
High School or equivalent
Position Type
Full time
This QA Sr. Manager role will be responsible for the quality oversight of one or more device suppliers. This person is an integral member of the Amgen cross-functional device supplier team that includes, but is not limited to, business operations, final product technologies, process development, supply chain and final product technologies quality.

Key Responsibilities
  • Quality liaison between Amgen and the device supplier
  • Negotiator and Approver of quality agreements
  • Prepare external site for inspections including development of inspection playbooks.
  • Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during Notified Body audits of supplier, as applicable or required
  • Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
  • Review/Approve supplier investigations, event and change notifications
  • Quality approver of deviations, change controls, CAPA, CAPA EVs
  • Identify and mitigate risk at the supplier and/or escalate to management
  • Perform Person in Plant activities as required
  • Manage audit commitments to completion
  • Perform tactical batch disposition activities in support of lot release
  • Continuously assess supplier status through periodic monitoring reporting
  • Partner with Operations site lead on issues, improvements, site performance and overall relationship management


Basic Qualifications

Doctorate degree and 2 years of Quality experience

OR

Master's degree and 6 years of Quality experience

OR

Bachelor's degree and 8 years of Quality experience

OR

Associate's degree and 10 years of Quality experience

OR

High school diploma / GED and 12 years Quality experience

Preferred Qualifications
  • 10 + years biotech or pharmaceutical industry experience
  • Experience with Quality Processes and systems such as QMTS and IRPC
  • History of involvement with inspection and audits
  • Able to facilitate and influence senior stakeholders and partners
  • Able to successfully manage workload and timelines
  • Familiarity with basic project management tools
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Strong project management, problem-solving, and analytical skills
  • Strong influencing skills
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
  • Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience driving decision making by using DAI principles
  • Experience with relationship management with external parties
  • Experience with the "variation management" process


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.