29 days old

Quality Assurance Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    120013855
Amgen

Job ID: R-98950
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Puerto Rico - Juncos, US - Rhode Island - West Greenwich, US - Massachusetts - Cambridge, US - Florida - Tampa

Amgen is seeking a Quality Assurance Manager to join our team and work from Amgen's beautiful campus.

Job Description

The Quality Assurance Manager will be on point for the Quality and Compliance oversight of lower risk external sites.

Key Responsibilities
  • Serve as the main Quality point of contact related to Amgen suppliers
  • Lead External site to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements
  • Review and/or approve 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 sites
  • Provide quality oversight of the manufacturing, testing, and release of Amgen materials at External sites
  • Author and drive impactful 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 impactful periodic reviews and operating reviews
  • Call out risks or roadblocks to management
  • Drive timely decision-making using DAI principles
  • Drive continuous improvements and Amgen first mentality

Authority

Decision to release or reject batches

Decision to approve or reject an External site change implementation / deviation

Advise on External site status and Inspection readiness

Identify opportunities and issues, then determine when escalation is necessary

Basic Qualifications :

Doctorate degree

OR

Master's degree & 3 years of quality and manufacturing experience in biotech or pharmaceutical industry

OR

Bachelor's degree & 5 years of quality and manufacturing experience in biotech or pharmaceutical industry

OR

Associate's degree & 10 years of quality and manufacturing experience in biotech or pharmaceutical industry

OR

High school diploma / GED & 12 years of quality and manufacturing experience in biotech or pharmaceutical industry

Preferred Qualifications:
  • Auditing or ASQ certification
  • Bachelor's Degree in a Science Field
  • Experience with Contract Labs (CL), Quality Control Labs and Contract Management Oversight (CMOs)
  • cGMP Experience
  • Ability to coordinate multiple projects simultaneously
  • Ability 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 timely, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Ability to handle diverse relationships
  • Ability to lead and run 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


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: 2020-05-01 Expires: 2020-06-01

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Quality Assurance Manager

Amgen
Thousand Oaks, CA 91360

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