Amgen

Quality Assurance Manager - External Site Lead

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 04, 2021
Ref
R-117441
Required Education
High School or equivalent
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Quality Assurance Manager

Live

What you will do

Lets do this. Lets change the world.

The Quality Assurance Manager will be responsible for quality and compliance oversight of external partners that are part of Amgens network of GMP service providers.

Key Responsibilities
  • Serve as the Quality Assurance point of contact for Amgen external partners/sites

  • Facilitate and support the business relationship between internal Amgen sites and external partners; act as point of contact for customer concerns and drive successful resolution of issues

  • Ensure external site performance is acceptable and aligned to Amgen business needs; implement recovery plans or mitigation actions when vital (pertains to timely delivery, adherence to cycle times, and ensure contractual obligations are being fulfilled as defined in the quality agreements, statements of work, etc.)

  • Review and/or approve executed production batch records, deviations, master batch records, change controls, and audit/inspection responses, and other quality records, etc.

  • Understand and interpret applicable GMP regulations pertaining to manufacturing and testing activities

  • Provide quality oversight of the manufacturing, testing, and release of Amgen materials

  • Author QA periodic monitoring reports summarizing external site performance; identify quality issues/risks and implement improvement plans as needed

  • Monitor and communicate site performance in terms of quality metrics through periodic monitoring reports, and or business/operating reviews

  • Author inspection playbooks with external site highlighting key risks/gaps and drive readiness activities

  • Represent Amgen in regulatory inspections and/or during notified body audits of external site

  • Support regulatory activities and requests for information as needed for filings, marketing applications, etc.

  • Identify risks or roadblocks to management; raise critical issues in a timely manner

  • Drive decision-making using DAI principles

  • Drive continuous improvements and Amgen first mentality

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The vital attribute professional we seek will have these qualifications.

Doctorate degree

OR

Masters degree & 3 years of quality and manufacturing experience in biotech or pharmaceutical industry

Or

Bachelors degree & 5 years of quality and manufacturing experience in biotech or pharmaceutical industry

Or

Associates 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:
  • Experience with Contract Labs (CL), Quality Control Labs and Contract Management (CMO) QA oversight

  • cGMP experience

  • Ability to travel +/- 10% of time to domestic and international Amgen/external sites

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear.

Join us. careers.amgen.com

#operations21

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.


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.