Amgen

Quality Sr. Manager, Site Lead

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-78488
Required Education
High School or equivalent
Position Type
Full time
The Quality Sr. Manager Site Lead is responsible for Quality and Compliance Oversight of the External Supplier which may include a contract testing laboratory, contract manufacturing site or a raw material supplier.

Additional Responsibilities:
  • Be an integral quality member of Amgen cross-functional external supply team that includes but is not limited to business operations, analytical sciences, process development, supply chain, and external process development.
  • Negotiator and approver of quality agreements
  • Lead the preparation of the site for and represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site, as applicable or required.
  • Present on topics during inspections, therefore demonstrating appropriate behaviors and knowledge of the subject areas
  • Review / approve Master Batch Records
  • Quality approver for deviations, change controls, CAPAs
  • Prepare inspection playbooks
  • Identify and mitigate risk at the external supplier site and/or escalate to management
  • Perform Person in Plant activities as required
  • Annual Product Review (APR) Data Provider
  • Manage audit commitments to completion
  • Perform tactical batch disposition activities in support of lot release


Basic Qualifications

Doctorate degree and 2 years of Quality and/or Manufacturing experience

OR

Master's degree and 6 years of Quality and/or Manufacturing experience

OR

Bachelor's degree and 8 years of Quality and/or Manufacturing experience

OR

Associate's degree and 10 years of Quality and/or Manufacturing experience

OR

High school diploma / GED and 12 years of Quality and/or Manufacturing experience

Preferred Qualifications
  • Bachelor's of Science degree
  • 10 + years biotech or pharmaceutical industry experience
  • Significant Quality and/or Manufacturing experience at Small Molecule manufacturing facilities
  • Significant Quality experience at Aseptic manufacturing facilities
  • Ability to facilitate and influence senior stakeholders and partners
  • Ability 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
  • 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 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.

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.