Amgen

QA Mgr

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-78195
Required Education
High School or equivalent
Position Type
Full time
The QA Manager - Site Lead is responsible for Quality and Compliance oversight of lower risk External sites. This role ensures External site activities are in alignment with applicable product CTA /Marketing Application.

Key Responsibilities
  • Serve as the main Quality point of contact related to Amgen product at External site
  • Execute Amgen Supplier audits
  • Manage External site to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements
  • Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
  • Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
  • Provide quality oversight of the manufacturing, testing, and release of Amgen products at External site
  • Author and drive actionable site inspection readiness plans
  • Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site
  • Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required
  • Identify and mitigate risk at the External site
  • Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
  • Escalate risks or roadblocks to management
  • Drive timely decision making using DAI principles
  • Drive continuous improvements and Amgen first mindset

Basic Qualifications:

Doctorate degree

OR

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

OR

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

OR

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

OR

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

Preferred Qualifications:
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's Degree in a Science Field
  • cGMP Experience
  • Auditor Certification or experience performing audits
  • Raw Material Compendial Testing proficiency
  • Knowledge of Single Use Systems, Resins, and filters in an aseptic manufacturing facility
  • Ability to oversee multiple projects simultaneously
  • Able to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Ability to manage diverse relationships
  • Ability to lead and manage cross-functional teams
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to travel +/- 10% of time to domestic and international Amgen/External sites

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.